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Multicenter ESG Trial (MERIT Trial)

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ClinicalTrials.gov Identifier: NCT03406975
Recruitment Status : Active, not recruiting
First Posted : January 23, 2018
Last Update Posted : December 19, 2020
Sponsor:
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  ICMJE January 16, 2018
First Posted Date  ICMJE January 23, 2018
Last Update Posted Date December 19, 2020
Actual Study Start Date  ICMJE December 20, 2017
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2018)
% EWL at 12 months from randomization [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2018)
Change in hypertension in treatment group compared to control (lifestyle) only [ Time Frame: 24 months ]
Original Secondary Outcome Measures  ICMJE 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  ICMJE Multicenter ESG Trial (MERIT Trial)
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Obesity
  • Hypertension
  • Diabetes Mellitus, Type 2
Intervention  ICMJE Device: Overstitch
Endoscopic sleeve gastroplasty
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 16, 2018)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03406975
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party Barham K. Abu Dayyeh, M.D., Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Barham K Abu Dayyeh Mayo Clinic
PRS Account Mayo Clinic
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP