CompletedNCT01647958TEMPOUpdated Nov 23, 2020Results posted

The EndoGastric Solutions TEMPO Trial

An interventional study of EsophyX System with SerosaFuse fasteners and PPI in Gastroesophageal Reflux Disease (GERD), sponsored by EndoGastric Solutions. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-23.

Sponsored by EndoGastric Solutions · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 65
Allocation: Randomized
Ages: 18 Years to 80 Years
Sex: All

Study summary

The purpose of this study is to assess the efficacy and safety of Transoral Incisionless Fundoplication (TIF) performed with EsophyX as compared to proton pump inhibitor (PPI) therapy for the treatment of chronic Gastroesophageal Reflux Disease (GERD) patients with refractory symptoms on Proton Pump Inhibitors (PPIs).

Read the detailed description

The objective of this study is to assess the efficacy and safety of TIF performed with EsophyX as compared to proton pump inhibitor (PPI) therapy for the treatment of chronic GERD patients with medically refractory GERD symptoms other than heartburn.

Primary hypothesis: TIF will be superior to PPIs in eliminating or significantly improving daily bothersome GERD symptoms and/or troublesome regurgitation, if present, at 6-month follow-up. Secondary hypotheses: TIF will be superior to PPIs in eliminating or significantly improving daily bothersome GERD symptoms and/or troublesome regurgitation, if present, at 12-, 24-, 36-, 48- and 60-month follow-up. The majority of surgical patients will have normalized or 50% improved esophageal acid exposure compared to baseline at 6-month follow-up. The majority of surgical patients will be completely off PPIs at 6-, 12-, 24-, 36-, 48- and 60-month follow-up compared to baseline. The majority of crossover patients will be completely off PPIs at 6-, 18-, 30-, 42- and 54-month follow-up compared to baseline. A statistically greater proportion of crossover patients treated with TIF will be free of daily bothersome symptom(s) or will experience clinically significant improvement at 6-, 18-, 30-, 42- and 54-month follow-up.

Conditions studied

Gastroesophageal Reflux Disease (GERD)

Browse trials for

Gastroesophageal Reflux 1,067

Keywords

TEMPO
TIF
Transoral Incisionless Fundoplication
EsophyX System
refractory symptoms
proton pump inhibitors
EndoGastric Solutions
EGS
Acid Reflux
Heartburn
Regurgitation

In context

Gastroesophageal Reflux

1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.

This study's enrollment of 65 is close to the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

EndoGastric Solutions is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Age 18-80 years;
GERD for > 1 year;
History of daily PPIs for > 6 months;
At least daily bothersome medically refractory GERD symptom(s) other than heartburn on PPIs;
Hill grade I and II at gastroesophageal junction;
Proven gastroesophageal reflux by either endoscopy, ambulatory pH or barium swallow testing;
Willingness to undergo pH testing;
Willingness to cooperate with the postoperative diet;
Availability for follow-up visits at 6, 12, 24, and 36 months;
Willingly and cognitively signed inform consent

Exclusion criteria

Exclusion Criteria:

BMI > 35 Hiatal hernia > 2c m in axial height and > 2 cm in greatest transverse dimension;
Esophagitis grade C and D;
Barrett's esophagus > 2 cm;
Esophageal ulcer;
Fixed esophageal stricture or narrowing;
Portal hypertension and/or varices;
Active gastro-duodenal ulcer disease; Gastric outlet obstruction or stenosis;
Gastroparesis;
Coagulation disorders;
History of any of the following: resective gastric or esophageal surgery, antireflux surgery with anatomy unsuitable for TIF procedure per physician judgment, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis;
Pregnancy or plans of pregnancy in the next 12 months;
Enrollment in another device or drug study that may confound the results

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 65 participants (actual)

Study arms

Experimental
Treatment Arm
Transoral incisionless esophago-gastric fundoplication using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following TIF2.0 protocol.
Device: EsophyX System with SerosaFuse fasteners
Active comparator
Control
Patients who are dependent upon daily PPIs will continue on single dose twice daily or increase to single dose twice daily for the first six months of the clinical trial. Patients will be offered TIF crossover procedure upon completion of month-6 follow-up visit.
Drug: PPI

Interventions

DeviceEsophyX System with SerosaFuse fasteners
Transoral Incisionless Fundoplication (TIF)/Transoral incisionless esophago-gastric fundoplication using the EsophyX System with SerosaFuse fasteners
DrugPPI
Control Arm participants will take maximum standard dose of PPI during Initial Study period
Also known as: same brand of PPI used by all Control Arm participants

What researchers measure

Primary outcomes

Number of Participants Reporting GERD (Gastroesophageal Reflux Disease) Symptom Elimination or Clinically Significant Improvement Evaluated by RSI (Reflux Symptom Index) and RDQ (Reflux Disease Questionnaire).
Elimination or clinically significant improvement in GERD symptoms, other than heartburn, refractory to PPI, evaluated by Reflux Symptom Index (RSI):9-item questionnaire measures atypical symptoms: hoarseness, throat clearing, excess throat mucus, dysphagia, cough. Scale for each item ranges from 0 (no problem) to 5 (severe), with max total score of 45, normality threshold of ≤13. Reflux Disease Questionnaire (RDQ):12-item questionnaire to assess frequency and severity of heartburn (4 items measure frequency/severity of pain and burning behind breastbone), regurgitation (4 items measure frequency/severity of acid taste in mouth and movement of material upward from stomach), and dyspeptic complaints (4 items measure frequency and severity of pain or burning in upper stomach). Responses from 0 (not present) to 5 (daily) for frequency and 0 (not present) to 5 (severe) for severity. Scores calculated as mean of item responses with higher scores indicating more severe or frequent symptoms.
Time frame: 6 months
Number of Participants Reporting Elimination of Daily Troublesome Regurgitation Using a Validated Questionnaire for Assessment
Elimination or clinically significant improvement in troublesome regurgitation refractory to PPIs as evaluated by the disease-specific and validated instrument, Reflux Disease Questionnaire (RDQ):12-item questionnaire assesses frequency and severity of heartburn (4 items measure frequency and severity of pain and burning behind breastbone), regurgitation (4 items measuring the frequency and severity of acid taste in mouth and movement of material upward from stomach), and dyspeptic complaints (4 items measure frequency and severity of pain or burning in upper stomach). Responses range from 0 (not present) to 5 (daily) for frequency and 0 (not present) to 5 (severe) for severity. Patient's score is calculated as the mean of item responses with higher scores indicating more severe or frequent symptoms. A frequency score of 3 or more and severity score of 2 or more for the regurgitation questions were required to meet the Montreal consensus criteria for troublesome regurgitation.
Time frame: 6 months

Secondary outcomes

Number of Participants With Complete PPI Discontinuation Assessed Using Validated Questionnaires and Participant-reported Discontinuation
Elimination of daily bothersome GERD (Gastro Esophageal Reflux Disease) HRQL symptoms, using RDQ (Reflux Disease Questionnaire), RSI (Reflux Symptom Index) and as measured by complete discontinuation of PPI (Proton Pump Inhibitors) therapy at 6-month follow-up.
Time frame: 6 Months
Number of Participants With Normalization of Esophageal Acid Exposure Assessed Using 48-hour pH Metry
Assessment of esophageal acid exposure with normal defined as pH\<4 in less than 5.3% total time exposure, using 48hr pH metry, with patients off PPIs for at least 7 days
Time frame: 6 Months
Number of Participants With Complete Healing or Reduction of Reflux Esophagitis, Assessed by EGD Using Los Angeles (LA) Grading
Esophagitis graded using the LA grading system through endoscopic visualization. Data entered represents study participants with complete healing or reduction in reflux esophagitis compared to baseline results. Note that Control arm patients were assessed while on PPIs. LA grades are A, B, C, D, with A being the least severe. Grade D was an exclusion criteria. Normal has no associated grade.
Time frame: 6 months

Other outcomes

Number of Participants With Elimination of Daily Troublesome Heartburn Assessed Using a Validated Questionnaire
Elimination of daily bothersome heartburn as measured by GERD-HRQL (Gastro Esophageal Reflux Disease - Health-Related Quality of Life) questionnaire. GERD-HRQL is a validated questionnaire used to assess typical GERD symptoms by measuring 10 items on the visual analog scale ranging from 0 (no symptoms) to 5 (worst symptoms). A higher total GERD-HRQL score (range from 0 to 50) indicates more severe GERD. Note Control Arm patients are assessed while on standard daily dose of PPIs.
Time frame: 6 months

Results

Posted Nov 2, 2020

Participant flow

Patients were recruited from seven U.S. hospitals.

Initial Study

Participant flow — Initial Study
Milestone	Treatment Arm	Control
Started	41	24
Completed	39	21
Not completed	2	3
Withdrew: Lost to follow-up	2	3

Continuation Phase

Participant flow — Continuation Phase
Milestone	Treatment Arm	Control
Started	39	21
Completed	0	21
Not completed	39	0
Withdrew: Treatment received during overall study	39	0

Extended Follow-up Phase

Participant flow — Extended Follow-up Phase
Milestone	Treatment Arm	Control
Started	60	0
Completed	52	0
Not completed	8	0
Withdrew: Lost to follow-up	8	0

Outcome measures

PrimaryNumber of Participants Reporting GERD (Gastroesophageal Reflux Disease) Symptom Elimination or Clinically Significant Improvement Evaluated by RSI (Reflux Symptom Index) and RDQ (Reflux Disease Questionnaire).

Elimination or clinically significant improvement in GERD symptoms, other than heartburn, refractory to PPI, evaluated by Reflux Symptom Index (RSI):9-item questionnaire measures atypical symptoms: hoarseness, throat clearing, excess throat mucus, dysphagia, cough. Scale for each item ranges from 0 (no problem) to 5 (severe), with max total score of 45, normality threshold of ≤13. Reflux Disease Questionnaire (RDQ):12-item questionnaire to assess frequency and severity of heartburn (4 items measure frequency/severity of pain and burning behind breastbone), regurgitation (4 items measure frequency/severity of acid taste in mouth and movement of material upward from stomach), and dyspeptic complaints (4 items measure frequency and severity of pain or burning in upper stomach). Responses from 0 (not present) to 5 (daily) for frequency and 0 (not present) to 5 (severe) for severity. Scores calculated as mean of item responses with higher scores indicating more severe or frequent symptoms.

Time frame:: 6 months
Reported as:: Count of participants · Participants

Number of Participants Reporting GERD (Gastroesophageal Reflux Disease) Symptom Elimination or Clinically Significant Improvement Evaluated by RSI (Reflux Symptom Index) and RDQ (Reflux Disease Questionnaire).
Participants	Treatment Arm	Control
Number of Participants Reporting GERD (Gastroesophageal Reflux Disease) Symptom Elimination or Clinically Significant Improvement Evaluated by RSI (Reflux Symptom Index) and RDQ (Reflux Disease Questionnaire).	24	1

PrimaryNumber of Participants Reporting Elimination of Daily Troublesome Regurgitation Using a Validated Questionnaire for Assessment

Elimination or clinically significant improvement in troublesome regurgitation refractory to PPIs as evaluated by the disease-specific and validated instrument, Reflux Disease Questionnaire (RDQ):12-item questionnaire assesses frequency and severity of heartburn (4 items measure frequency and severity of pain and burning behind breastbone), regurgitation (4 items measuring the frequency and severity of acid taste in mouth and movement of material upward from stomach), and dyspeptic complaints (4 items measure frequency and severity of pain or burning in upper stomach). Responses range from 0 (not present) to 5 (daily) for frequency and 0 (not present) to 5 (severe) for severity. Patient's score is calculated as the mean of item responses with higher scores indicating more severe or frequent symptoms. A frequency score of 3 or more and severity score of 2 or more for the regurgitation questions were required to meet the Montreal consensus criteria for troublesome regurgitation.

Time frame:: 6 months
Reported as:: Count of participants · Participants

Number of Participants Reporting Elimination of Daily Troublesome Regurgitation Using a Validated Questionnaire for Assessment
Participants	Treatment Arm	Control Arm
Number of Participants Reporting Elimination of Daily Troublesome Regurgitation Using a Validated Questionnaire for Assessment	29	9

SecondaryNumber of Participants With Complete PPI Discontinuation Assessed Using Validated Questionnaires and Participant-reported Discontinuation

Elimination of daily bothersome GERD (Gastro Esophageal Reflux Disease) HRQL symptoms, using RDQ (Reflux Disease Questionnaire), RSI (Reflux Symptom Index) and as measured by complete discontinuation of PPI (Proton Pump Inhibitors) therapy at 6-month follow-up.

Time frame:: 6 Months
Reported as:: Count of participants · Participants

Number of Participants With Complete PPI Discontinuation Assessed Using Validated Questionnaires and Participant-reported Discontinuation
Participants	Treatment Arm	Control Arm
Number of Participants With Complete PPI Discontinuation Assessed Using Validated Questionnaires and Participant-reported Discontinuation	35	0

SecondaryNumber of Participants With Normalization of Esophageal Acid Exposure Assessed Using 48-hour pH Metry

Assessment of esophageal acid exposure with normal defined as pH\<4 in less than 5.3% total time exposure, using 48hr pH metry, with patients off PPIs for at least 7 days

Time frame:: 6 Months
Reported as:: Count of participants · Participants

Number of Participants With Normalization of Esophageal Acid Exposure Assessed Using 48-hour pH Metry
Participants	Treatment Arm	Control Arm
Number of Participants With Normalization of Esophageal Acid Exposure Assessed Using 48-hour pH Metry	21	11

SecondaryNumber of Participants With Complete Healing or Reduction of Reflux Esophagitis, Assessed by EGD Using Los Angeles (LA) Grading

Esophagitis graded using the LA grading system through endoscopic visualization. Data entered represents study participants with complete healing or reduction in reflux esophagitis compared to baseline results. Note that Control arm patients were assessed while on PPIs. LA grades are A, B, C, D, with A being the least severe. Grade D was an exclusion criteria. Normal has no associated grade.

Time frame:: 6 months
Reported as:: Count of participants · Participants

Number of Participants With Complete Healing or Reduction of Reflux Esophagitis, Assessed by EGD Using Los Angeles (LA) Grading
Participants	Treatment Arm	Control Arm
Number of Participants With Complete Healing or Reduction of Reflux Esophagitis, Assessed by EGD Using Los Angeles (LA) Grading	18	5

Other pre-specifiedNumber of Participants With Elimination of Daily Troublesome Heartburn Assessed Using a Validated Questionnaire

Elimination of daily bothersome heartburn as measured by GERD-HRQL (Gastro Esophageal Reflux Disease - Health-Related Quality of Life) questionnaire. GERD-HRQL is a validated questionnaire used to assess typical GERD symptoms by measuring 10 items on the visual analog scale ranging from 0 (no symptoms) to 5 (worst symptoms). A higher total GERD-HRQL score (range from 0 to 50) indicates more severe GERD. Note Control Arm patients are assessed while on standard daily dose of PPIs.

Time frame:: 6 months
Reported as:: Count of participants · Participants

Number of Participants With Elimination of Daily Troublesome Heartburn Assessed Using a Validated Questionnaire
Participants	Treatment Arm	Control Arm
Number of Participants With Elimination of Daily Troublesome Heartburn Assessed Using a Validated Questionnaire	28	2

Post-hocNumber of Participants With GERD Symptom Control Following TIF and Crossover TIF, Assessed by Validated Questionnaires (Primary Endpoint)

Assess number of patients reporting global elimination of troublesome regurgitation and atypical symptoms using Reflux Disease Questionnaire (RDQ), a 12-item questionnaire to assess frequency and severity of heartburn (4 items measure frequency/severity of pain and burning behind breastbone), regurgitation (4 items measure frequency/severity of acid taste in mouth and movement of material upward from stomach), and dyspeptic complaints (4 items measure frequency and severity of pain or burning in upper stomach). Responses from 0 (not present) to 5 (daily) for frequency and 0 (not present) to 5 (severe) for severity, and Reflux Symptom Index (RSI), a 9-item questionnaire to assess atypical symptoms: hoarseness, throat clearing, excess throat mucus, dysphagia, cough. Scale for each item ranges from 0 (no problem) to 5 (severe), with max score of 45, normality threshold of ≤13. Scores calculated as mean of item responses with higher scores indicating more severe or frequent symptoms.

Time frame:: 12 months
Reported as:: Count of participants · Participants

Number of Participants With GERD Symptom Control Following TIF and Crossover TIF, Assessed by Validated Questionnaires (Primary Endpoint)
Participants	Treatment Arm	Control Arm
Number of Participants With GERD Symptom Control Following TIF and Crossover TIF, Assessed by Validated Questionnaires (Primary Endpoint)	30	13

Post-hocNumber of Participants Reporting Elimination of Troublesome Regurgitation Assessed Using a Validated Questionnaire (Primary Endpoint)

Assessment of the number of patients reporting elimination of troublesome regurgitation using the validated Reflux Disease Questionnaire (RDQ), a 12-item questionnaire to assess frequency and severity of heartburn (4 items measure frequency/severity of pain and burning behind breastbone), regurgitation (4 items measure frequency/severity of acid taste in mouth and movement of material upward from stomach), and dyspeptic complaints (4 items measure frequency and severity of pain or burning in upper stomach). Responses from 0 (not present) to 5 (daily) for frequency and 0 (not present) to 5 (severe) for severity A frequency score of three or more and severity score of two or more for the regurgitation questions were required to meet the Montreal consensus criteria for troublesome regurgitation. The lower the score the better the outcome. (Crossover patients are 6-months post TIF.)

Time frame:: 12 months
Reported as:: Count of participants · Participants

Number of Participants Reporting Elimination of Troublesome Regurgitation Assessed Using a Validated Questionnaire (Primary Endpoint)
Participants	Treatment Arm	Control Arm
Number of Participants Reporting Elimination of Troublesome Regurgitation Assessed Using a Validated Questionnaire (Primary Endpoint)	28	6

Post-hocNumber of Participants With Healing of Esophagitis After TIF and Crossover TIF (Secondary Endpoint)

Assessment of number of participants reporting healed esophagitis after TIF using EGD and LA grading system. Treatment arm patients assessed at 12 month post TIF and Control arm patients are at 6 month post Crossover TIF (12 month post randomization). LA grading A, B, C, D, with A the least severe esophagitis. No grade listed is "Normal". Grade D is an exclusion criteria.

Time frame:: 12 months
Reported as:: Count of participants · Participants

Number of Participants With Healing of Esophagitis After TIF and Crossover TIF (Secondary Endpoint)
Participants	Treatment Arm	Control Arm
Number of Participants With Healing of Esophagitis After TIF and Crossover TIF (Secondary Endpoint)	19	11

Post-hocNumber of Participants With Normal Esophageal Acid Exposure Assessed Post-TIF and Post-Crossover TIF (Secondary Endpoint)

Assessment of esophageal acid exposure with normal defined as pH\<4 in less than 5.3% total time exposure, using 48hr pH metry, with patients off PPIs for at least 7 days.

Time frame:: 12 months
Reported as:: Count of participants · Participants

Number of Participants With Normal Esophageal Acid Exposure Assessed Post-TIF and Post-Crossover TIF (Secondary Endpoint)
Participants	Treatment Arm	Control Arm
Number of Participants With Normal Esophageal Acid Exposure Assessed Post-TIF and Post-Crossover TIF (Secondary Endpoint)	17	7

Post-hocNumber of Participants Completely Off Daily PPIs Following TIF and Crossover TIF (Secondary Endpoint)

Number of patients reporting complete cessation of daily PPI therapy at 12 months post TIF and 6 months post Crossover TIF. This is patient-reported.

Time frame:: 12 months
Reported as:: Count of participants · Participants

Number of Participants Completely Off Daily PPIs Following TIF and Crossover TIF (Secondary Endpoint)
Participants	Treatment Arm	Control Arm
Number of Participants Completely Off Daily PPIs Following TIF and Crossover TIF (Secondary Endpoint)	32	15

Post-hocNumber of Participants Reporting Elimination of Troublesome Regurgitation Assessed Using a Validated Questionnaire (Primary Endpoint)

Assessment of the number of patients reporting elimination of troublesome regurgitation using the validated Reflux Disease Questionnaire (RDQ), a 12-item questionnaire to assess frequency and severity of heartburn (4 items measure frequency/severity of pain and burning behind breastbone), regurgitation (4 items measure frequency/severity of acid taste in mouth and movement of material upward from stomach), and dyspeptic complaints (4 items measure frequency and severity of pain or burning in upper stomach). Responses from 0 (not present) to 5 (daily) for frequency and 0 (not present) to 5 (severe) for severity. A frequency score of three or more and severity score of two or more for the regurgitation questions were required to meet the Montreal consensus criteria for troublesome regurgitation. The cohort of patients reported includes Treatment arm patients and Crossover patients combined as one group. Crossover patients included in the cohort are 30 months post TIF.

Time frame:: 36 months
Reported as:: Count of participants · Participants

Number of Participants Reporting Elimination of Troublesome Regurgitation Assessed Using a Validated Questionnaire (Primary Endpoint)
Participants	Treatment Arm	Control Arm
Number of Participants Reporting Elimination of Troublesome Regurgitation Assessed Using a Validated Questionnaire (Primary Endpoint)	37	0

Post-hocNumber of Study Participants Reporting Elimination of All Troublesome Atypical GERD Symptoms Assessed by Reflux Symptom Index (RSI) (Primary Endpoint)

Assessment of atypical GERD symptoms (symptoms other than heartburn) using validated Reflux Symptom Index (RSI), a 9 item questionnaire with a 0-5 score for each, for a total of 45, and a normality threshold of ≤13. The lower the score the better the outcome. Control/Crossover arm patients included in this cohort are at 30 months post TIF.

Time frame:: 36 months
Reported as:: Count of participants · Participants

Number of Study Participants Reporting Elimination of All Troublesome Atypical GERD Symptoms Assessed by Reflux Symptom Index (RSI) (Primary Endpoint)
Participants	Treatment Arm	Control Arm
Number of Study Participants Reporting Elimination of All Troublesome Atypical GERD Symptoms Assessed by Reflux Symptom Index (RSI) (Primary Endpoint)	42	0

Post-hocNumber of Participants With pH Normalization at 3-year Follow-up (Secondary Endpoint)

Assessment of esophageal acid exposure with normal defined as pH\<4 in less than 5.3% total time exposure, using 48hr pH metry, with patients off PPIs for at least 7 days. Note that patients originally in the Control/Crossover arm are at 30 months post TIF at this follow up period. Treatment and Control/Crossover patients are reported as a single cohort.

Time frame:: 36 months
Reported as:: Count of participants · Participants

Number of Participants With pH Normalization at 3-year Follow-up (Secondary Endpoint)
Participants	Treatment Arm	Control Arm
Number of Participants With pH Normalization at 3-year Follow-up (Secondary Endpoint)	16	0

Post-hocNumber of Participants With Complete Discontinuation of Daily PPI Therapy (Secondary Endpoint)

Number of patients reporting complete cessation of daily PPI therapy at 36 months post TIF and 30 months post Crossover TIF combined into a single cohort.

Time frame:: 36 months
Reported as:: Count of participants · Participants

Number of Participants With Complete Discontinuation of Daily PPI Therapy (Secondary Endpoint)
Participants	Treatment Arm	Control Arm
Number of Participants With Complete Discontinuation of Daily PPI Therapy (Secondary Endpoint)	37	0

Post-hocNumber of Participants With Healed Esophagitis (Secondary Endpoint)

Assessment of number of participants reporting healed esophagitis after TIF using EGD and LA grading system, LA grade A, B, C, D, with A meaning least severe esophagitis. No grade means normal. 30 months post TIF for Crossover patients.

Time frame:: 36 months
Reported as:: Count of participants · Participants

Number of Participants With Healed Esophagitis (Secondary Endpoint)
Participants	Treatment Arm	Control Arm
Number of Participants With Healed Esophagitis (Secondary Endpoint)	19	0

Post-hocNumber of Patients Satisfied With Their Current Health Condition (Secondary Endpoint)

Satisfaction with current health condition OFF PPIs is reported as part of the GERD health-related quality of life questionnaire (GERD-HRQL), with 3 possible answers: satisfied, neutral or dissatisfied.

Time frame:: 36 months
Reported as:: Count of participants · Participants

Number of Patients Satisfied With Their Current Health Condition (Secondary Endpoint)
Participants	Treatment Arm	Control Arm
Number of Patients Satisfied With Their Current Health Condition (Secondary Endpoint)	35	0

Post-hocNumber of Participants With Elimination of Daily Troublesome Regurgitation (Primary Endpoint)

Number of patients reporting elimination of troublesome regurgitation using the validated Reflux Disease Questionnaire (RDQ), a 12-item questionnaire to assess frequency and severity of heartburn (4 items measure frequency/severity of pain and burning behind breastbone), regurgitation (4 items measuring frequency/severity of acid taste in mouth and movement of material upward from stomach), and dyspeptic complaints (4 items measure frequency/severity of pain or burning in upper stomach). 9 response options range from 0 (not present) to 5 (daily) for frequency and 0 (not present) to 5 (severe) for severity. Each patient's score is calculated as the mean of item responses, with higher scores indicating more frequent and/or severe symptoms. Cohort of patients reported at this time period includes Treatment arm patients and Control/Crossover patients combined as 1 group. Control/Crossover patients included in cohort are at 54 months post TIF.

Time frame:: 60 months
Reported as:: Count of participants · Participants

Number of Participants With Elimination of Daily Troublesome Regurgitation (Primary Endpoint)
Participants	Treatment Arm	Control Arm
Number of Participants With Elimination of Daily Troublesome Regurgitation (Primary Endpoint)	37	0

Post-hocNumber of Patients With Elimination of Troublesome Atypical GERD Symptoms (Primary Endpoint)

Number of patients with elimination of troublesome GERD symptoms using Reflux Symptom Index (RSI), a 9-item validated questionnaire to measure atypical GERD symptoms such as hoarseness, throat clearing, excess throat mucus, dysphagia, and cough. The scale for each individual item ranges from 0 (no problem) to 5 (severe problem), with a maximum total score of 45 and a normality threshold of ≤13. The lower the score, the better the outcome.

Time frame:: 60 months
Reported as:: Count of participants · Participants

Number of Patients With Elimination of Troublesome Atypical GERD Symptoms (Primary Endpoint)
Participants	Treatment Arm	Control Arm
Number of Patients With Elimination of Troublesome Atypical GERD Symptoms (Primary Endpoint)	31	0

Post-hocNumber of Patients Reporting Complete Cessation of Daily PPIs (Secondary Endpoint)

Number of participants with complete cessation of daily PPI use, self-reported by patient at 60 month follow-up. (54 months for Control/crossover patients). Note: all patients were on daily PPIs at screening (100%).

Time frame:: 60 months
Reported as:: Count of participants · Participants

Number of Patients Reporting Complete Cessation of Daily PPIs (Secondary Endpoint)
Participants	Treatment Arm	Control Arm
Number of Patients Reporting Complete Cessation of Daily PPIs (Secondary Endpoint)	20	0

Post-hocNumber of Participants Satisfied With Their Current Health Condition (Secondary Endpoint)

Time frame:: 60 months
Reported as:: Count of participants · Participants

Number of Participants Satisfied With Their Current Health Condition (Secondary Endpoint)
Participants	Treatment Arm	Control Arm
Number of Participants Satisfied With Their Current Health Condition (Secondary Endpoint)	31	0

Post-hocNumber of Participants Undergoing Reoperation Post-TIF (Secondary Endpoint)

Reoperations completed post TIF by the end of 60 month (54 months post Crossover) follow up. These included 2 Laparoscopic Nissen fundoplications and 1 Dor fundoplication, completed without difficulty. This number includes the two reoperations reported and included in number of participants analyzed, at 36 month follow up.

Time frame:: 60 months
Reported as:: Count of participants · Participants

Number of Participants Undergoing Reoperation Post-TIF (Secondary Endpoint)
Participants	Treatment Arm	Control Arm
Number of Participants Undergoing Reoperation Post-TIF (Secondary Endpoint)	3	0

Adverse events

Collected over Adverse event data was collected over a period of 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Treatment Arm	0/41 (0%)	0/41 (0%)	2/41 (4.9%)
Control	0/24 (0%)	0/24 (0%)	0/24 (0%)

Most frequent other events

Most frequent other events
Event	Treatment Arm	Control
Post operative TIF procedureGastrointestinal disorders	1/41	0/24
Post operative TIF procedureGeneral disorders	1/41	0/24

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Treatment Arm	Control	Total
<=18 years	0	0	0
Between 18 and 65 years	34	21	55
>=65 years	5	0	5

Age, Continuous
Age, Continuous(years)	Treatment Arm	Control	Total
Median	54.8 (35.7 to 73.3)	50.1 (32.5 to 63.3)	53.16 (32.5 to 73.3)

Sex: Female, Male
Sex: Female, Male(Participants)	Treatment Arm	Control	Total
Female	20	13	33
Male	19	8	27

Region of Enrollment
Region of Enrollment(Participants)	Treatment Arm	Control	Total
United States	39	21	60

Study locations

1 site

EndoGastric Solutions
Redmond, Washington 98052, United States

References and documents

Publications

Trad KS, Simoni G, Barnes WE, Shughoury AB, Raza M, Heise JA, Turgeon DG, Fox MA, Mavrelis PG. Efficacy of transoral fundoplication for treatment of chronic gastroesophageal reflux disease incompletely controlled with high-dose proton-pump inhibitors therapy: a randomized, multicenter, open label, crossover study. BMC Gastroenterol. 2014 Oct 6;14:174. doi: 10.1186/1471-230X-14-174. PubMed 25284142 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 23, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01647958
Lead sponsor: EndoGastric Solutions
Responsible party: Sponsor
First posted: Jul 24, 2012
Start date: Jun 1, 2012
Primary completion: Oct 1, 2015
Completion: Dec 1, 2017
Results posted: Nov 2, 2020
Last update: Nov 23, 2020

Study contacts

Karim Trad, MD, FACS

principal investigator · Reston Surgical Associates

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Gastroesophageal Reflux→

Other studies from this sponsor

EndoGastric Solutions

Start the discussion