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Multicenter ESG Trial (MERIT Trial)

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ClinicalTrials.gov Identifier: NCT03406975
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : January 16, 2019
Sponsor:
Collaborators:
University of Texas
Johns Hopkins University
Brigham and Women's Hospital
NorthShore University HealthSystem
University of Chicago
Orlando Health
Information provided by (Responsible Party):
Barham K. Abu Dayyeh, M.D., Mayo Clinic

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 8 locations in the United States will participate in this study.

The ESG procedure has been performed clinically for 3 years 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
Obesity Hypertension Diabetes Mellitus, Type 2 Device: Overstitch Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 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 : December 20, 2017
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 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
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. All ESG patients in 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




Primary Outcome Measures :
  1. % EWL at 12 months from randomization [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Change in hypertension in treatment group compared to control (lifestyle) only [ Time Frame: 24 months ]

Other Outcome Measures:
  1. Change in type II diabetes in the treatment group compared to control (lifestyle) only [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

    • 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 ≤ 8, and c) 24 or less patients with BMI between 40-45kg/m²; 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03406975


Locations
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United States, Florida
Orlando Health Recruiting
Orlando, Florida, United States, 32806
Contact: Paula Willett    321-841-9623    Paula.Willett@orlandohealth.com   
Principal Investigator: Andre Teixeira, MD         
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Kia Donboli    773-926-8490    kdonboli@medicine.bsd.uchicago.edu   
Principal Investigator: Christopher Chapman, MD         
NorthShore University Health System Recruiting
Evanston, Illinois, United States, 60201
Contact: Eliza Conaty    847-570-1239    EConaty@northshore.org   
Principal Investigator: Michael Ujiki, MD         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21224
Contact: Lea Fayad, MD    410-550-0796    leafayad3@jhmi.edu   
Principal Investigator: Vivek Kumbhari, MD         
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Michele Ryan    617-732-6389    MRYAN@BWH.HARVARD.EDU   
Principal Investigator: Christopher Thompson, MD         
United States, Minnesota
Mayo Clinic in Rochester Completed
Rochester, Minnesota, United States, 55905
United States, South Dakota
Avera McKennan Hospital & University Health Center Recruiting
Sioux Falls, South Dakota, United States, 57105
Contact: Kim McCoy    605-322-1320    Kim.McCoy@avera.org   
Principal Investigator: Bradley Thaemert, MD         
United States, Texas
University of Texas Recruiting
Houston, Texas, United States, 77401
Contact: Angie Riveria    713-486-1350    Angielyn.R.Rivera@uth.tmc.edu   
Principal Investigator: Erik Wilson, MD         
Sponsors and Collaborators
Mayo Clinic
University of Texas
Johns Hopkins University
Brigham and Women's Hospital
NorthShore University HealthSystem
University of Chicago
Orlando Health
Investigators
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Principal Investigator: Barham K Abu Dayyeh Mayo Clinic

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Responsible Party: Barham K. Abu Dayyeh, M.D., Barham Abu Dayyeh, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03406975     History of Changes
Other Study ID Numbers: 17-007934
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases