Multicenter ESG Trial (MERIT Trial)

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.