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

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT03406975
Collaborator
University of Texas (Other), Johns Hopkins University (Other), Brigham and Women's Hospital (Other), NorthShore University HealthSystem (Other), University of Chicago (Other), Orlando Health, Inc. (Other), Cornell University (Other), Avera McKennan Hospital & University Health Center (Other)
208
Enrollment
9
Locations
2
Arms
45.8
Actual Duration (Months)
23.1
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Overstitch
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
208 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Multi-center ESG Randomized Interventional Trial (MERIT-Trial)
Actual Study Start Date :
Dec 20, 2017
Actual Primary Completion Date :
Oct 29, 2020
Actual Study Completion Date :
Oct 15, 2021

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Control Group: Lifestyle Modification

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.

Device: Overstitch
Endoscopic sleeve gastroplasty
Active Comparator: Treatment Group: ESG Procedure

Participants randomized to the treatment group will proceed to have the Overstitch Edoscopic 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

Device: Overstitch
Endoscopic sleeve gastroplasty

Outcome Measures

Primary Outcome Measures

  1. % EWL at 12 months from randomization [12 months]

Secondary Outcome Measures

  1. Change in hypertension in treatment group compared to control (lifestyle) only [24 months]

Other Outcome Measures

  1. Change in type II diabetes in the treatment group compared to control (lifestyle) only [24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Orlando Health Orlando Florida United States 32806
2 University of Chicago Chicago Illinois United States 60637
3 NorthShore University Health System Evanston Illinois United States 60201
4 Johns Hopkins University Baltimore Maryland United States 21224
5 Brigham and Women's Hospital Boston Massachusetts United States 02115
6 Mayo Clinic in Rochester Rochester Minnesota United States 55905
7 Cornell University New York New York United States 10065
8 Avera McKennan Hospital & University Health Center Sioux Falls South Dakota United States 57105
9 University of Texas Houston Texas United States 77401

Sponsors and Collaborators

  • Mayo Clinic
  • 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Barham K. Abu Dayyeh, M.D., Barham Abu Dayyeh, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT03406975
Other Study ID Numbers:
  • 17-007934
First Posted:
Jan 23, 2018
Last Update Posted:
Mar 16, 2022
Last Verified:
Mar 1, 2022
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
Additional relevant MeSH terms:
Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Mar 16, 2022