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

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 17-007934
    NCT ID: NCT03406975
    Sponsor Protocol Number: 17-007934

About this study

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. We 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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Age 21-65.
  • BMI ≥ 30 and ≤ kg/m².
  • Willingness to comply with the substantial lifelong dietary restrictions required by the procedure.
  • History of failure with non-surgical weight-loss methods.
  • Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory tests, and completing diet counseling.
  • Residing within a reasonable distance from the investigator’s office and able to travel to the investigator to complete all routine follow- up visits.
  • Ability to give informed consent.
  • 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 ≤ 9, and , Obesity HTH, Obesity DM) and block randomized. No more than 50 participants without comorbidities will be enrolled in the trial.

Exclusion Criteria:

  • History of foregut or gastrointestinal (GI) surgery (except uncomplicated cholecystectomy or appendectomy).
  • Prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions.
  • Prior open or laparoscopic bariatric surgery.
  • Prior surgery of any kind on the esophagus, stomach or any type of hiatal hernia surgery.
  • 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.
  • 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.
  • A gastric mass or gastric polyps > 1 cm in size.
  • A hiatal hernia > 4cm of axial displacement of the z-line above the diaphragm or severe or intractable gastro-esophageal reflux symptoms.
  • A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the endoscope.
  • Achalasia or any other severe esophageal motility disorder.
  • Severe coagulopathy.
  • 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.
  • Subjects with any serious health condition unrelated to their weight that would increase the risk of endoscopy.
  • Chronic abdominal pain.
  • Motility disorders of the GI tract such as gross esophageal motility disorders, gastroparesis or intractable constipation.
  • Hepatic insufficiency or cirrhosis.
  • Use of an intragastric device prior to this study due to the increased thickness of the stomach wall preventing effective suturing.
  • Active psychological issues preventing participation in a life-style modification program as determined by a psychologist.
  • Patients unwilling to participate in an established medically-supervised diet and behavior modification program, with routine medical follow-up.
  • Patients receiving daily prescribed treatment with high dose aspirin (> 80mg daily), anti-inflammatory agents, anticoagulants or other gastric irritants.
  • Patients who are unable or unwilling to take prescribed proton pump inhibitor medication.
  • Patients who are pregnant or breast-feeding.
  • 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.
  • Subjects taking medications on specified hourly intervals that may be affected by changes to gastric emptying, such as anti-seizure or anti-arrhythmic medications.
  • Subjects who are taking corticosteroids, immunosuppressants, and narcotics.
  • Subjects who are taking diet pills.
  • Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease.
  • Pre-existing respiratory disease such as moderate or severe chronic obstructive pulmonary disease (COPD) requiring steroids, pneumonia or cancer.
  • Diagnosis of autoimmune connective tissue disorder (e.g. lupus, erythematous, scleroderma) or immunocompromised.
  • Specific diagnosed genetic disorder such as Prader Willi syndrome.
  • Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating.
  • Known history of endocrine disorders affecting weight such as uncontrolled hypothyroidism.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Barham Abu Dayyeh, M.D., M.P.H.

Open for enrollment

Contact information:

Erik Hyland

(507)284-4723

Hyland.Erik@mayo.edu