Multicenter Endoscopic Sleeve Gastrectomy (ESG) Trial (MERIT Trial)

September 24, 2022 updated by: Barham K. Abu Dayyeh, M.D., Mayo Clinic

Multi-center ESG Randomized Interventional Trial (MERIT-Trial)

Endoscopic Sleeve Gastroplasty (ESG) is an endoscopic minimally invasive weight loss procedure where a commercially available, FDA approved, full-thickness endoscopic suturing device (Overstitch; Apollo Endosurgery, Austin, TX) is used to reduce the stomach volume by 80% through the creation of a restrictive endoscopic sleeve. This is accomplished by a series of endoscopically placed full-thickness sutures through the gastric wall, extending from the antrum to the gastroesophageal junction.

Up to 200 participants at 9 locations in the United States will participate in this study.

The ESG procedure has been performed clinically since 2013 in the United States. The investigators are completing this study to compare how effective the ESG is for achieving long-term weight loss when compared to lifestyle modification only, as well as to evaluate the long-term safety and durability of the procedure and its impact on quality of life. Results of this research may help support having this procedure covered by health insurance plans for future patients.

Study Overview

Study Type

Interventional

Enrollment (Actual)

208

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Orlando, Florida, United States, 32806
        • Orlando Health
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University Of Chicago
      • Evanston, Illinois, United States, 60201
        • Northshore University Health System
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester
    • New York
      • New York, New York, United States, 10065
        • Cornell University
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Avera McKennan Hospital & University Health Center
    • Texas
      • Houston, Texas, United States, 77401
        • University of Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

INCLUSION CRITERIA

  1. Age 21-65
  2. BMI ≥ 30 and ≤40 kg/m²
  3. Willingness to comply with the substantial lifelong dietary restrictions required by the procedure
  4. History of failure with non-surgical weight-loss methods
  5. Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory tests, and completing diet counseling
  6. Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete all routine follow- up visits
  7. Ability to give informed consent
  8. Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods
  9. ***There will be a quota for at least a) 50 patients with hypertension on one or more anti-hypertensive medication, b) 50 patients with type II diabetes mellitus on oral agents only with HgA1c ≤ 9, and thus the cohort of 200 patients will be stratified into three groups (Obesity, Obesity HTH, Obesity DM) and block randomized. No more than 50 participants without comorbidities will be enrolled in the trial.

EXCLUSION CRITERIA

  1. History of foregut or gastrointestinal (GI) surgery (except uncomplicated cholecystectomy or appendectomy)
  2. Prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions.
  3. Prior open or laparoscopic bariatric surgery.
  4. Prior surgery of any kind on the esophagus, stomach or any type of hiatal hernia surgery.
  5. Any inflammatory disease of the gastrointestinal tract including esophagitis, Barrett's esophagus, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease.
  6. Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses.
  7. A gastric mass or gastric polyps > 1 cm in size.
  8. A hiatal hernia > 4cm of axial displacement of the z-line above the diaphragm or severe or intractable gastro-esophageal reflux symptoms.
  9. A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the endoscope.
  10. Achalasia or any other severe esophageal motility disorder
  11. Severe coagulopathy.
  12. Insulin-dependent diabetes (either Type 1 or Type 2) or a significant likelihood of requiring insulin treatment in the following 12 months or a HgbA1C >= 9.
  13. Subjects with any serious health condition unrelated to their weight that would increase the risk of endoscopy
  14. Chronic abdominal pain
  15. Motility disorders of the GI tract such as gross esophageal motility disorders, gastroparesis or intractable constipation
  16. Hepatic insufficiency or cirrhosis
  17. Use of an intragastric device prior to this study due to the increased thickness of the stomach wall preventing effective suturing.
  18. Active psychological issues preventing participation in a life-style modification program as determined by a psychologist
  19. Patients unwilling to participate in an established medically-supervised diet and behavior modification program, with routine medical follow-up.
  20. Patients receiving daily prescribed treatment with high dose aspirin (> 80mg daily), anti-inflammatory agents, anticoagulants or other gastric irritants.
  21. Patients who are unable or unwilling to take prescribed proton pump inhibitor medication
  22. Patients who are pregnant or breast-feeding.
  23. Subjects with Severe cardiopulmonary disease or other serious organic disease which might include known history of coronary artery disease, Myocardial infarction within the past 6 months, poorly-controlled hypertension, required use of NSAIDs
  24. Subjects taking medications on specified hourly intervals that may be affected by changes to gastric emptying, such as anti-seizure or anti-arrhythmic medications
  25. Subjects who are taking corticosteroids, immunosuppressants, and narcotics
  26. Subjects who are taking diet pills
  27. Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease.
  28. Pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer.
  29. Diagnosis of autoimmune connective tissue disorder (e.g. lupus, erythematous, scleroderma) or immunocompromised.
  30. Specific diagnosed genetic disorder such as Prader Willi syndrome.
  31. Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating
  32. Known history of endocrine disorders affecting weight such as uncontrolled hypothyroidism.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group: Lifestyle Modification
Participants randomized to the control group (lifestyle modification only) in Year 1 will undergo a standard moderate intensity life-style intervention during the first 12 months of participation.
Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.
Experimental: Treatment Group: Overstitch ESG Procedure
Participants randomized to the treatment group will proceed to have the Overstitch Endoscopic Sleeve Gastroplasty (ESG) at the start of Year 1 and will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. All patients undergoing ESG will go on a 6 weeks transitional diet.ESG patients will undergo a standard moderate intensity life-style intervention administered over 15 12 visits in the first year after ESG. ESG patients who have not achieved >25% EWL at the end of Year 1 will undergo a repeat upper endoscopy at 52 to 60 weeks to assess the durability of the plications. Patients will continue follow-up with a modified lifestyle intervention program administered over 6 visits in the second year
Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.
Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall.
Experimental: Crossover Group: Lifestyle Intervention to ESG Procedure
Control group participants (lifestyle modification only) who were compliant with at least 75% of visits in Year 1, have not achieved ≥25% EWL or have a BMI >30 measured at the week 52 visit, and have no new psychosocial contraindications as deemed by the treatment team to the procedure will cross over to receive the Overstitch ESG in Year 2, in addition to the standard moderate intensity lifestyle intervention program of 12 months.
Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.
Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Excess Weight Loss (EWL)
Time Frame: 12 months
Percentage of excess weight loss in participants at 12 months from randomization. Calculated as (weight loss/baseline excess weight) x 100, where weight loss is defined as follow-up weight minus the initial weight, and baseline excess weight is defined as index weight minus ideal weight X (X=25 kg/m²)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With ≥25% EWL
Time Frame: 12 months
Total number of participants with ≥25% excess weight loss at 12 months from randomization
12 months
Number of Participants Off Or With Reduction in Antihypertensive Medications
Time Frame: 12 months
Total number participants off or with reduction in antihypertensive medications
12 months
Change in Blood Pressure
Time Frame: Baseline, 12 months
Change in blood pressure measured in units of millimeters of mercury (mmHg)
Baseline, 12 months
Change in Blood Pressure for ESG Intervention From Baseline to 24 Months
Time Frame: Baseline, 24 months
Change in blood pressure for participants that received ESG intervention measured in units of millimeters of mercury (mmHg)
Baseline, 24 months
Number of Participants Off or With Reduction in Diabetes Medications
Time Frame: 12 months
Total number of participants off or with reduction in diabetes medications
12 months
Change in HgbA1c
Time Frame: Baseline, 12 months
Change in HgbA1c levels
Baseline, 12 months
Change in HgbA1c for ESG Intervention From Baseline to 24 Months
Time Frame: Baseline, 24 months
Change in HgbA1c levels for participants that received the ESG intervention
Baseline, 24 months
Percentage of Total Body Weight Loss (TBWL)
Time Frame: 12 months
Percentage of total body weight loss in participants
12 months
Number of Participants to Achieve ≥5% TBWL
Time Frame: 12 months
Total number of participants to achieve ≥5% total body weight loss
12 months
Number of Participants to Achieve ≥10% TBWL
Time Frame: 12 months
Total number of participants to achieve ≥10% total body weight loss
12 months
Esophagitis at Repeat Endoscopy
Time Frame: 12 months
Total number of participants to have esophagitis at repeat endoscopy
12 months
Change in Impact of Weight on Quality of Life-Lite (IWQOL-Lite)
Time Frame: Baseline, 12 months
Changes in impact of weight on quality of life score assessed using self-reported IWQOL-lite questionnaire consisting of five domains: physical function (11 items, score range from 11-55 with higher scores indicating more negative outcome), self-esteem (7 items, score range from 7-35 with higher scores indicating more negative outcome), sexual life (4 items, score range from 4-20 with higher scores indicating more negative outcome), public distress (5 items, score range from 5-25 with higher scores indicating more negative outcome), and work (4 items, score range from 4-20 with higher scores indicating more negative outcome).
Baseline, 12 months
Changes in Health Status Survey Scores
Time Frame: Baseline, 12 months
Changes in subject's view of health assessed using self-reported SF-36 Health Status Survey consisting of 8 scaled scores: physical function (10-items, score range from 0-100 with higher scores indicating more positive outcome), role limitations due to physical health (4-items, score range from 0-100 with higher scores indicating more positive outcome), role limitations due to emotional problems (3-item, score range from 0-100 with higher scores indicating more positive outcome), energy/fatigue (4-items, score range from 0-100 with higher scores indicating more positive outcome), emotional well-being (5-items, score range from 0-100 with higher scores indicating more positive outcome), social functioning (2-items, score range from 0-100 with higher scores indicating more positive outcome), pain (2-items, score range from 0-100 with higher scores indicating more positive outcome), general health (5-items, score range from 0-100 with higher scores indicating more positive outcome)
Baseline, 12 months
Number of Participants With Major Depression or Severe Major Depression at Baseline
Time Frame: Baseline
Number of participants to identify with major or severe major depression measured using the self-reported Patient Health Questionnaire (PHQ-9). The PHQ-9 is self-reported 9-item questionnaire to assess degree of depression severity with total score range from 0-27 categories were defined as followed: minimal, score < 10; major depression, 10 ≤ score < 20; severe major depression, x ≥ 20
Baseline
Number of Participants With Major Depression or Severe Major Depression at 12 Months
Time Frame: 12 months
Number of participants to identify with major or severe major depression measured using the self-reported Patient Health Questionnaire (PHQ-9). The PHQ-9 is self-reported 9-item questionnaire to assess degree of depression severity with total score range from 0-27 categories were defined as followed: minimal, score < 10; major depression, 10 ≤ score < 20; severe major depression, x ≥ 20
12 months
Change in Eating Behaviors
Time Frame: Baseline, 12 months
Change in eating behaviors evaluated using the self-reported Three Factor Eating Questionnaire (TFEQ) consisting of 3 domains: cognitive restraint (6-items, score range from 0-100 with higher score indicating more restraint), uncontrolled eating (9-items, score range from 0-100 with lower score indicating more control), and emotional eating (3-items, score range 0-100 with higher score indicating eating with negative emotions)
Baseline, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2017

Primary Completion (Actual)

October 29, 2020

Study Completion (Actual)

October 15, 2021

Study Registration Dates

First Submitted

January 16, 2018

First Submitted That Met QC Criteria

January 16, 2018

First Posted (Actual)

January 23, 2018

Study Record Updates

Last Update Posted (Actual)

October 18, 2022

Last Update Submitted That Met QC Criteria

September 24, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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