Multicenter ESG Trial (MERIT Trial)

• ClinicalTrials.gov Identifier: NCT03406975
• Recruitment Status: Active, not recruiting
• First Posted: January 23, 2018
• Last Update Posted: December 19, 2020
• Sponsor: Mayo Clinic
• Collaborators: University of Texas; Johns Hopkins University; Brigham and Women's Hospital; NorthShore University HealthSystem; University of Chicago; Orlando Health, Inc.; Cornell University; Avera McKennan Hospital & University Health Center
• Information provided by (Responsible Party): Barham K. Abu Dayyeh, M.D., Mayo Clinic

Tracking Information

• First Submitted Date: January 16, 2018
• First Posted Date: January 23, 2018
• Last Update Posted Date: December 19, 2020
• Actual Study Start Date: December 20, 2017
• Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 16, 2018): % EWL at 12 months from randomization [ Time Frame: 12 months ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: January 16, 2018): Change in hypertension in treatment group compared to control (lifestyle) only [ Time Frame: 24 months ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures (submitted: January 16, 2018): Change in type II diabetes in the treatment group compared to control (lifestyle) only [ Time Frame: 24 months ]
• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Multicenter ESG Trial (MERIT Trial)
• Official Title: Multi-center ESG Randomized Interventional Trial (MERIT-Trial)

Brief Summary

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 endolumenally 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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Other

Condition

• Obesity
• Hypertension
• Diabetes Mellitus, Type 2

Intervention

Device: Overstitch

Endoscopic sleeve gastroplasty

Study Arms

• Placebo Comparator: Control Group
  Participants randomized to the control group (lifestyle intervention only) in Year 1 will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. Control group participants 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 for 12 months.
  Intervention: Device: Overstitch
• Active Comparator: Treatment Group
  Participants randomized to the treatment group will proceed to have the Overstitch 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
  Intervention: Device: Overstitch

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: January 16, 2018): 200
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2021
• Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03406975
• Other Study ID Numbers: 17-007934
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

• IPD Sharing Statement: Not Provided
• Responsible Party: Barham K. Abu Dayyeh, M.D., Mayo Clinic
• Study Sponsor: Mayo Clinic

Collaborators

• University of Texas
• Johns Hopkins University
• Brigham and Women's Hospital
• NorthShore University HealthSystem
• University of Chicago
• Orlando Health, Inc.
• Cornell University
• Avera McKennan Hospital & University Health Center

Investigators

• Principal Investigator: Barham K Abu Dayyeh; Mayo Clinic

• PRS Account: Mayo Clinic
• Verification Date: December 2020