An interventional study of EndoFLIP in Esophagogastric Junction Distensibility and Hiatal Hernia, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Treatment
The investigators aim to ascertain the effects of hiatal hernia repair and fundoplication on the distensibility of the esophagogastric junction (EGJ) as measured by FLIP topography/impedance planimetry. The investigators also aim to assess for any correlation between values of EGJ distensibility and GERD related quality of life (QOL) and dysphagia scores.
Patients referred for antireflux surgery and/or hiatal hernia repair will be considered for enrollment. Standard preoperative evaluation will include esophagogastroduodenoscopy (EGD) to assess for intraluminal pathology including esophagitis, columnar lined esophagus suggestive of Barrett's esophagus, intraluminal masses, and to measure hernia size. Patients will also undergo preoperative high resolution esophageal manometry testing with impedance as clinically indicated to evaluate esophageal motility as assessed by standardized Chicago Classification V3. Manometry will occasionally be avoided in patients with paraesophageal hernias without substantial dysphagia or those not amenable to manometry, with appropriate upper gastrointestinal radiology imaging (UGI), who will be having partial fundoplications. UGI is also a routine preoperative evaluation. Furthermore, pH testing for evaluation of acid reflux will be performed in patients without LA grade C or D esophagitis, paraesophageal hernia, or pathologic confirmation of Barrett's esophagus.
Patients appropriate for enrollment will be consented in the office setting. Preoperative baseline evaluations of symptom severity will be assessed via the GERD-HRQL survey and Mayo Dysphagia Questionnaire. Surgery will be scheduled and patients will undergo intraoperative impedance planimetry with EndoFLIP obtaining measurements of the cross-sectional area, balloon pressure, minimum diameter, compliance, length of high pressure segment, and distensibility index of the EGJ using an 8cm EndoFLIP balloon. Sequential assessments will be performed to 30ml and 40ml for up to a minute for each volume of distension. An initial baseline measurement will be obtained after establishment of pneumoperitoneum. A second measurement will occur following hiatal dissection and mobilization but prior to crural closure. Two additional measurements will be obtained after hiatal closure and after fundoplication.
No adjustment will be made to the surgical procedure based on EndoFLIP results, as the operating surgeon will not be informed of the measured values. The EndoFLIP catheters and generator will be provided by Medtronic, at no cost to the patient. Medtronic will also cover the fees associated with the EndoFLIP procedure (CPT 91040 is used).
Postoperative clinical care will proceed as per standard protocol for foregut surgery, with 1 additional office visit. Reports of postoperative symptomatology and quality of life will be performed, via GERD-HRQL and Mayo Dysphagia Questionnaire during follow up clinic appointments at 2 weeks and 6 weeks postoperative, and with additional long-term follow-up of at 6 months. Long-term follow-up will again assess for quality of life symptoms via GERD-HRQL and the Mayo Dysphagia Questionnaire. The 6 month follow-up visit is not typical practice and the patients cost for this visit will be covered by Medtronic. Per standard clinical care, recurrence of symptoms or dysphagia at any point may lead to additional postoperative testing, including UGI, EGD, pH testing, esophageal manometry, CT scan, or EndoFLIP. Postoperative GERD-HRQL and Mayo Dysphagia score results will be compared to intraoperative EndoFLIP measurements in interim and final analysis.
87 studies on the registry are indexed under Hernia, Hiatal; 27 are open to participants now.
This study's enrollment of 28 is below the median of 100 across 56 interventional studies indexed under Hernia, Hiatal.
Browse Hernia, Hiatal studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergoing hiatal hernia repair (types I-IV included) and fundoplication
Device: EndoFLIP
Intraoperative impedance planimetry with EndoFLIP obtaining measurements of the cross-sectional area, balloon pressure, minimum diameter, compliance, length of high pressure segment, and distensibility index of the esophagogastric junction using an 8cm EndoFLIP balloon. Sequential assessments will be performed to 30ml and 40ml for up to a minute for each volume of distension. An initial baseline measurement will be obtained after establishment of pneumoperitoneum. A second measurement will occur following hiatal dissection and mobilization but prior to crural closure. Two additional measurements will be obtained after hiatal closure and after fundoplication.
Change in Distensibility Index
Distensibility index of esophagogastric junction will be measured with 8cm EndoFLIP balloon at baseline and after hiatal hernia repair.
Time frame: Baseline to day 1
Gastroesophageal Reflux Disease Health Related Quality of Life Questionnaire (GERD-HRQL) Score
Postoperative symptoms as measured by GERD-HRQL. Total score range is 0-75. Higher scores are correlated with worse outcomes.
Time frame: baseline, postop week 2, postop week 6, postop month 6
Mayo Dysphagia Questionnaire (MDQ-30) Score
Postoperative symptoms as measured by the MDQ-30. Totals core range is 0-100. Higher scores are correlated with worse outcomes.
Time frame: baseline, postop week 2, postop week 6, postop month 6
| Milestone | Hiatal Hernia Repair Patients |
|---|---|
| Started | 28 |
| Completed | 19 |
| Not completed | 9 |
| Withdrew: Physician decision | 5 |
| Withdrew: Not eligible | 3 |
| Withdrew: Withdrawal by subject | 1 |
Distensibility index of esophagogastric junction will be measured with 8cm EndoFLIP balloon at baseline and after hiatal hernia repair.
| mm²/mmHg | Hiatal Hernia Repair Patients |
|---|---|
| Change in Distensibility Index | 0.72 ± 1.8 |
Postoperative symptoms as measured by GERD-HRQL. Total score range is 0-75. Higher scores are correlated with worse outcomes.
Results for this outcome have not been posted.
Postoperative symptoms as measured by the MDQ-30. Totals core range is 0-100. Higher scores are correlated with worse outcomes.
Results for this outcome have not been posted.
Collected over 1 day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Hiatal Hernia Repair Patients | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Age, Continuous(years) | Hiatal Hernia Repair Patients |
|---|---|
| Median | 62.2 ± 12.7 |
| Sex: Female, Male(Participants) | Hiatal Hernia Repair Patients |
|---|---|
| Female | 17 |
| Male | 2 |
| Ethnicity (NIH/OMB)(Participants) | Hiatal Hernia Repair Patients |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 18 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Hiatal Hernia Repair Patients |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 17 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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