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CompletedNCT03515811Updated May 10, 2024Results posted

A Post Market Study to Confirm the Safety and Performance of the Signia™ Stapling System.

An observational study in Abdominal Injury and Thoracic Diseases, sponsored by Medtronic - MITG. Completed at 11 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-10.

Sponsored by Medtronic - MITG (part of Medtronic) · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
136
Ages
18 Years and older
Sex
All
01

Study summary

The objectives of this prospective, two-arm, multicenter post-market study is to confirm safety and performance through the incidence of subjects reporting serious adverse device effects (ADEs) up to and including 30 days following use of Signia™ Stapling System with Endo GIA™ with Tri-Staple™ Technology and Tri-Staple™ 2.0 Intelligent Reloads in subjects undergoing indicated abdominal or thoracic procedures for resection, transection and creation of anastomosis per the IFU.

Read the detailed description

This study will evaluate the use of Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads in indicated abdominal or thoracic procedures (e.g., resection, transection of tissue, and creation of anastomoses). Subjects who meet the eligibility criteria will be considered for study participation at a minimum of 10 sites and will be followed up to and including 30 days post-operative. Overall the study is estimated to progress for up to 24 months.

02

Conditions studied

  • Abdominal Injury
  • Thoracic Diseases
03

In context

Abdominal Injuries

72 studies on the registry are indexed under Abdominal Injuries; 18 are open to participants now.

This study's enrollment of 136 is below the median of 200 across 38 observational studies indexed under Abdominal Injuries.

Browse Abdominal Injuries studies →

Lead sponsor

Medtronic - MITG is the lead sponsor of 178 studies on the registry; 4 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.

Browse Medtronic - MITG studies →All Medtronic studies →

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

74 Thoracic subjects arm 53 abdominal subjects arm

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Adults (male or female) between 22 and 80 years of age inclusive at the time of the procedure.
  2. The subject must be willing and able to participate in the study procedures and to understand and sign the informed consent.
  3. The subject is scheduled to undergo an indicated primary abdominal or thoracic procedure for resection, transection and creation of anastomosis per the IFU where the Signia™ Stapling System with Endo GIA™ with Tri-Staple™ Technology and Tri-Staple™ 2.0 Intelligent Reloads will be used per its IFU.Additionally, if considered appropriate for the procedure only Medtronic buttresses can be used during the course of the study.

3a. Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures.

3b. Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB).

Exclusion criteria

Exclusion Criteria:

  1. Subjects undergoing cardiac and vascular procedures.
  2. The procedure is an emergency procedure.
  3. The procedure is a revision/reoperation of a primary operation..
  4. Any female subject who is pregnant. 4a. Females of child-bearing potential will be required to undergo either a urine pregnancy test or serum pregnancy test during Screening and confirmed on the day of operation (except for subjects who are surgically sterile or are post-menopausal for at least two years) (USA only) and per EU local requirements.
  5. Any subject who is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity).
  6. The subject is unable or unwilling to comply with the study requirements or follow-up schedule.
  7. The subject has comorbidities which, in the clinical judgment of the Investigator, will not be appropriate for the study or the subject has an estimated life expectancy of less than 6 months.
  8. The subject has been diagnosed with a bleeding disorder and/or is undergoing active and not reversed anticoagulant treatment.
  9. The subject is concurrently enrolled in another investigational drug or device research study or has been enrolled in another study within 30 days of enrollment.
  10. Pre-existing/chronic conditions specific to Tri-Staple™ 2.0 Reload contraindications as described in the IFU.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
136 participants (actual)
Patient registry
No

Groups and cohorts

  • Abdominal

    Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads. Abdominal (approximately 53 subjects).

    Device: Signia™ Stapling System

  • Thoracic

    Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads. Thoracic (approximately 74 subjects).

    Device: Signia™ Stapling System

Interventions

  • DeviceSignia™ Stapling System

    Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.

06

What researchers measure

Primary outcomes

  1. The Primary Endpoint is the Number of Subjects Reporting Serious Adverse Device Effects (SADEs), Including Intra- and Post-operative Leaks.

    The primary endpoint is the number of subjects reporting serious adverse device effects (SADEs) up to and including 30 days, including intra- and post-operative leaks. A Serious Adverse Device Effect (SADE) is an adverse event related to the use of an investigational medical device, that is deemed serious in nature. To be deemed serious, and adverse event must meet one or more of the following criteria: Led to a death, b. Led to a serious deterioration in the health of the subject, that either resulted in: 1. Resulted in a life-threatening illness or injury, or 2. Resulted in a permanent impairment of a body structure or a body function, or 3. In-patient or prolonged hospitalization, or 4. Medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function, or c. Led to fetal distress, fetal death or a congenital abnormality or birth defect.

    Time frame: Up to and including 30 days intra- and post-operative.

  2. The Primary Endpoint is the Number of Subjects Reporting Serious Adverse Device Effects (SADEs), Including Intra- and Post-operative Leaks.

    The primary endpoint is the number of subjects reporting serious adverse device effects (SADEs), including intra- and post-operative leaks up to and including 30 (+14) days post-procedure. A Serious Adverse Device Effect (SADE) is an adverse event related to the use of an investigational medical device, that is deemed serious in nature. To be deemed serious, and adverse event must meet one or more of the following criteria: Led to a death, b. Led to a serious deterioration in the health of the subject, that either resulted in: 1. Resulted in a life-threatening illness or injury, or 2. Resulted in a permanent impairment of a body structure or a body function, or 3. In-patient or prolonged hospitalization, or 4. Medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function, or c. Led to fetal distress, fetal death or a congenital abnormality or birth defect.

    Time frame: Up to and including 30 (+14) days post-procedure.

Secondary outcomes

  1. The Secondary Endpoint is Device Deficiencies/Malfunctions Affecting the Intended Performance of the Device.

    The secondary endpoint is device deficiencies/malfunctions affecting the intended performance of the device. All recorded device deficiencies/malfunctions were captured and assessed by the Investigator. A Device Deficiency is defined as inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance. Note: Device deficiencies include malfunctions, use errors, and inadequate labeling.

    Time frame: Up to and including 30 (+14) days post-operative.

  2. The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Staple Line Integrity (B Formation).

    The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. B formation is defined as consistent formation of the staple-line fired by the Signia Stapling System handle.

    Time frame: Up to and including 30 (+14) days post-operative.

  3. The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Number of Staple-line Bleeding (Measured as > 50 cc) Occurrences.

    The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. Number of staple-line bleeding (measured as \> 50 cc) refers to occurrences of bleeding at the staple-line only, and not in the study procedure as a whole.

    Time frame: Up to and including 30 (+14) days post-operative.

  4. The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Additional Interventions to Treat Staple-line Failure.

    The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. Examples of additional interventions to treat staple-line failure include: glue, manual over sew, Medtronic buttress as additional reinforcement, or intraoperative revision/recreation of the anastomosis.

    Time frame: Up to and including 30 (+14) days post-operative.

  5. The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Number of Intra-operative Leakage.

    The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. Number of intra-operative leakage as measured by air leak test performed by the surgeon, or standard of care, as applicable.

    Time frame: Up to and including 30 (+14) days post-operative.

  6. The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Number of Post-operative Leakage.

    The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. Number of post-operative leakage as evidenced confirmed by imaging, subject presentation or decline in status, or need for re-operation/re-intervention.

    Time frame: Up to and including 30 (+14) days post-operative.

  7. The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Duration of Air Leakage >7 Days.

    The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. Prolonged air leaks are considered \>7 days in duration.

    Time frame: Up to and including 30 (+14) days post-operative.

  8. The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Number of Post-operative Infection.

    The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. Number of post-operative infection was assessed by the Investigator according to the standard of care and site policy, ex. Positive wound culture.

    Time frame: Up to and including 30 (+14) days post-operative.

  9. The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Additional Interventions to Treat Staple-line Failure.

    The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. Examples of additional interventions to treat staple-line failure include: glue, manual over sew, Medtronic buttress as additional reinforcement, or intraoperative revision/recreation of the anastomosis.

    Time frame: Up to and including 30 (+14) days post-operative.

  10. The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Number of Repeat Hospital Admissions for Primary Procedure-related Complications.

    The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. The number of repeat hospital admissions for primary procedure-related complications was assessed.

    Time frame: Up to and including 30 (+14) days post-operative.

07

Results

Posted Mar 31, 2023
Limitations and caveats
There were no limitations or caveats in this study.

Participant flow

Participant flow — Overall Study
MilestoneAbdominalThoracic
Started5185
Completed4677
Not completed58
Withdrew: Lost to follow-up21
Withdrew: Protocol violation11
Withdrew: Death11
Withdrew: Withdrawal by subject02
Withdrew: Technical problems10
Withdrew: Subject unable to return for follow-up02
Withdrew: Covid-1901

Outcome measures

PrimaryThe Primary Endpoint is the Number of Subjects Reporting Serious Adverse Device Effects (SADEs), Including Intra- and Post-operative Leaks.

The primary endpoint is the number of subjects reporting serious adverse device effects (SADEs) up to and including 30 days, including intra- and post-operative leaks. A Serious Adverse Device Effect (SADE) is an adverse event related to the use of an investigational medical device, that is deemed serious in nature. To be deemed serious, and adverse event must meet one or more of the following criteria: Led to a death, b. Led to a serious deterioration in the health of the subject, that either resulted in: 1. Resulted in a life-threatening illness or injury, or 2. Resulted in a permanent impairment of a body structure or a body function, or 3. In-patient or prolonged hospitalization, or 4. Medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function, or c. Led to fetal distress, fetal death or a congenital abnormality or birth defect.

Time frame:
Up to and including 30 days intra- and post-operative.
Reported as:
Count of participants · Participants
The Primary Endpoint is the Number of Subjects Reporting Serious Adverse Device Effects (SADEs), Including Intra- and Post-operative Leaks.
ParticipantsAbdominalThoracic
The Primary Endpoint is the Number of Subjects Reporting Serious Adverse Device Effects (SADEs), Including Intra- and Post-operative Leaks.09
Statistical analysis
  • Thoracic · Percentage and confidence interval: 10.6 · 95% CI 5.0 to 19.295% CI: 5.0%-19.2%
  • Abdominal · Percentage and confidence interval: 0.0 · 95% CI 0.0 to 7.095% CI: 0.0%-7.0%
PrimaryThe Primary Endpoint is the Number of Subjects Reporting Serious Adverse Device Effects (SADEs), Including Intra- and Post-operative Leaks.

The primary endpoint is the number of subjects reporting serious adverse device effects (SADEs), including intra- and post-operative leaks up to and including 30 (+14) days post-procedure. A Serious Adverse Device Effect (SADE) is an adverse event related to the use of an investigational medical device, that is deemed serious in nature. To be deemed serious, and adverse event must meet one or more of the following criteria: Led to a death, b. Led to a serious deterioration in the health of the subject, that either resulted in: 1. Resulted in a life-threatening illness or injury, or 2. Resulted in a permanent impairment of a body structure or a body function, or 3. In-patient or prolonged hospitalization, or 4. Medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function, or c. Led to fetal distress, fetal death or a congenital abnormality or birth defect.

Time frame:
Up to and including 30 (+14) days post-procedure.
Reported as:
Count of participants · Participants
The Primary Endpoint is the Number of Subjects Reporting Serious Adverse Device Effects (SADEs), Including Intra- and Post-operative Leaks.
ParticipantsOverall
The Primary Endpoint is the Number of Subjects Reporting Serious Adverse Device Effects (SADEs), Including Intra- and Post-operative Leaks.9
Statistical analysis
  • Overall · Percentage and confidence interval: 6.6 · 95% CI 3.1 to 12.295% CI: 3.1%-12.2%
SecondaryThe Secondary Endpoint is Device Deficiencies/Malfunctions Affecting the Intended Performance of the Device.

The secondary endpoint is device deficiencies/malfunctions affecting the intended performance of the device. All recorded device deficiencies/malfunctions were captured and assessed by the Investigator. A Device Deficiency is defined as inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance. Note: Device deficiencies include malfunctions, use errors, and inadequate labeling.

Time frame:
Up to and including 30 (+14) days post-operative.
Reported as:
Count of participants · Participants
The Secondary Endpoint is Device Deficiencies/Malfunctions Affecting the Intended Performance of the Device.
ParticipantsAbdominalThoracic
The Secondary Endpoint is Device Deficiencies/Malfunctions Affecting the Intended Performance of the Device.22
SecondaryThe Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Staple Line Integrity (B Formation).

The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. B formation is defined as consistent formation of the staple-line fired by the Signia Stapling System handle.

Time frame:
Up to and including 30 (+14) days post-operative.
Reported as:
Count of participants · Participants
The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Staple Line Integrity (B Formation).
ParticipantsAbdominalThoracic
The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Staple Line Integrity (B Formation).4455
SecondaryThe Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Number of Staple-line Bleeding (Measured as > 50 cc) Occurrences.

The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. Number of staple-line bleeding (measured as \> 50 cc) refers to occurrences of bleeding at the staple-line only, and not in the study procedure as a whole.

Time frame:
Up to and including 30 (+14) days post-operative.
Reported as:
Count of participants · Participants
The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Number of Staple-line Bleeding (Measured as > 50 cc) Occurrences.
ParticipantsAbdominalThoracic
The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Number of Staple-line Bleeding (Measured as > 50 cc) Occurrences.00
SecondaryThe Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Additional Interventions to Treat Staple-line Failure.

The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. Examples of additional interventions to treat staple-line failure include: glue, manual over sew, Medtronic buttress as additional reinforcement, or intraoperative revision/recreation of the anastomosis.

Time frame:
Up to and including 30 (+14) days post-operative.
Reported as:
Count of participants · Participants
The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Additional Interventions to Treat Staple-line Failure.
ParticipantsAbdominalThoracic
The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Additional Interventions to Treat Staple-line Failure.342
SecondaryThe Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Number of Intra-operative Leakage.

The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. Number of intra-operative leakage as measured by air leak test performed by the surgeon, or standard of care, as applicable.

Time frame:
Up to and including 30 (+14) days post-operative.
Reported as:
Count of participants · Participants
The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Number of Intra-operative Leakage.
ParticipantsAbdominalThoracic
The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Number of Intra-operative Leakage.05
SecondaryThe Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Number of Post-operative Leakage.

The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. Number of post-operative leakage as evidenced confirmed by imaging, subject presentation or decline in status, or need for re-operation/re-intervention.

Time frame:
Up to and including 30 (+14) days post-operative.
Reported as:
Count of participants · Participants
The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Number of Post-operative Leakage.
ParticipantsAbdominalThoracic
The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Number of Post-operative Leakage.07
SecondaryThe Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Duration of Air Leakage >7 Days.

The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. Prolonged air leaks are considered \>7 days in duration.

Time frame:
Up to and including 30 (+14) days post-operative.
Reported as:
Count of participants · Participants
The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Duration of Air Leakage >7 Days.
ParticipantsAbdominalThoracic
The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Duration of Air Leakage >7 Days.03
SecondaryThe Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Number of Post-operative Infection.

The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. Number of post-operative infection was assessed by the Investigator according to the standard of care and site policy, ex. Positive wound culture.

Time frame:
Up to and including 30 (+14) days post-operative.
Reported as:
Count of participants · Participants
The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Number of Post-operative Infection.
ParticipantsAbdominalThoracic
The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Number of Post-operative Infection.18
SecondaryThe Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Additional Interventions to Treat Staple-line Failure.

The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. Examples of additional interventions to treat staple-line failure include: glue, manual over sew, Medtronic buttress as additional reinforcement, or intraoperative revision/recreation of the anastomosis.

Time frame:
Up to and including 30 (+14) days post-operative.
Reported as:
Count of participants · Participants
The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Additional Interventions to Treat Staple-line Failure.
ParticipantsAbdominalThoracic
The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Additional Interventions to Treat Staple-line Failure.02
SecondaryThe Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Number of Repeat Hospital Admissions for Primary Procedure-related Complications.

The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. The number of repeat hospital admissions for primary procedure-related complications was assessed.

Time frame:
Up to and including 30 (+14) days post-operative.
Reported as:
Count of participants · Participants
The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Number of Repeat Hospital Admissions for Primary Procedure-related Complications.
ParticipantsAbdominalThoracic
The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Number of Repeat Hospital Admissions for Primary Procedure-related Complications.14

Adverse events

Collected over Adverse events were collected up to and including 30 (+14) days post-procedure.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Abdominal1/51 (2%)6/51 (11.8%)0/51 (0%)
Thoracic1/85 (1.2%)21/85 (24.7%)31/85 (36.5%)
Most frequent serious events
Showing 10 of 24
Most frequent serious events
EventAbdominalThoracic
PneumothoraxRespiratory, thoracic and mediastinal disorders0/518/85
PneumoniaInfections and infestations0/513/85
Pleural effusionRespiratory, thoracic and mediastinal disorders0/513/85
Subcutaneous emphysemaSkin and subcutaneous tissue disorders0/513/85
Atrial fibrillationCardiac disorders0/512/85
Abdominal painGastrointestinal disorders1/510/85
Abdominal pain upperGastrointestinal disorders1/510/85
DehydrationMetabolism and nutrition disorders1/510/85
Pain in extremityMusculoskeletal and connective tissue disorders1/510/85
SyncopeNervous system disorders1/510/85
Most frequent other events
Most frequent other events
EventAbdominalThoracic
PneumothoraxRespiratory, thoracic and mediastinal disorders0/5115/85
Subcutaneous emphysemaSkin and subcutaneous tissue disorders0/519/85
Post-operative leakSurgical and medical procedures0/517/85

Baseline characteristics

Age, Continuous
Age, Continuous(years)AbdominalThoracicTotal
Median48.0 ± 13.2568.0 ± 10.1662.5 ± 14.23
Sex: Female, Male
Sex: Female, Male(Participants)AbdominalThoracicTotal
Female403575
Male115061
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)AbdominalThoracicTotal
Hispanic or Latino14519
Not Hispanic or Latino374986
Unknown or Not Reported03131
Race (NIH/OMB)
Race (NIH/OMB)(Participants)AbdominalThoracicTotal
American Indian or Alaska Native000
Asian123
Native Hawaiian or Other Pacific Islander000
Black or African American11415
White3879117
More than one race101
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)AbdominalThoracicTotal
Canada055
United States383876
Italy01818
United Kingdom01313
Spain131124
Pregnancy Test Performed
Pregnancy Test Performed(Participants)AbdominalThoracicTotal
Count of participants20727
08

Study locations

11 sites
  • Cedars Sinai Medical Center
    Los Angeles, California 90048, United States
  • Albany Medical College
    Albany, New York 12208, United States
  • WakeMed Bariatric Specialists of North Carolina
    Cary, North Carolina 27518, United States
  • UNC Chapel Hill
    Chapel Hill, North Carolina 27599, United States
  • Duke Regional Hospital
    Durham, North Carolina 27710, United States
  • Inova Fairfax Hospital
    Falls Church, Virginia 22042, United States
  • Institut Universitaire de Cardiologie et de Pneumologie de Quebec
    Québec, Quebec G1V4G5, Canada
  • Azienda Ospedaleria San Gerardo
    Monza, 20900, Italy
  • Hospital Universitario del Rocio
    Seville, 41009, Spain
  • Hospital Universitario Virgen Macarena
    Seville, 41009, Spain
  • Blackpool Victoria Hospital
    Blackpool, NE2 4NQ, United Kingdom
09

References and documents

Study documents

  • Study protocol · Aug 10, 2018
  • Statistical analysis plan · Mar 8, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2019 to primary completion in Jul 2020, 17 months.

Results were first posted in Mar 2023, 2 years 8 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 23, 2018
First posted
May 4, 2018
StartActual
Jan 22, 2019
Primary completionActual
Jul 13, 2020
CompletionActual
Jul 13, 2020
Results first posted
Mar 31, 2023
Last update
May 10, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03515811
Lead sponsor
Medtronic - MITG
Responsible party
Sponsor
First posted
May 4, 2018
Start date
Jan 22, 2019
Primary completion
Jul 13, 2020
Completion
Jul 13, 2020
Results posted
Mar 31, 2023
Last update
May 10, 2024

Study contacts

Kelley Kennedy
study director · Medtronic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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