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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
1. Male or females patients in the range of class I to class III obesity (BMI ≥ 30 to ≤
40 with obesity-related comorbidity or BMI > 40 to BMI ≤ 45).
2. Age 22 - 60 yrs.
3. Treatment naïve for bariatric surgery or endoscopic bariatric therapy
4. Agree to avoid any use of weight loss medications such as Meridia, Saxenda, Januvia,
Xenical, Duromine or over the counter weight loss medications or supplements
throughout the study.
5. Women of childbearing potential (WOCBP) must agree to use acceptable contraception
6. Agree not to donate blood during their participation in the study.
7. Able to comply with study requirements and understand and sign the Informed Consent
8. Stable weight defined as a fluctuation of less than 5% for at least 3 months prior to
9. History of failure to lose weight using conventional diet and lifestyle therapies.
1. Patients requiring exogenous insulin.
2. HbA1c > 8.5 %
3. Pregnant or breast-feeding or intending to get pregnant during the study.
4. Unwilling or unable to complete the Visual Analogue Scale for pain assessment, patient
questionnaires, or comply with study visits and other study procedures as required per
5. History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
6. Probable insulin production failure, defined as fasting C-Peptide serum < 1 ng/mL (333
7. Previous use of any types of insulin for > 1 month (at any time, except for treatment
of gestational diabetes).
8. Change in diabetic treatment within the last three months.
9. Use of glucose-lowering drugs for diabetes mellitus treatment with the exception of
sulfonylurea (SU), biguanides and sodium dependent glucose co-transporter 2 (SGLT-2)
10. Change of diabetes medication or doses 12 weeks prior to screening visit.
11. Hypoglycemia unawareness or a history of severe hypoglycemia (more than 1 severe
hypoglycemic event, as defined by need for third-party-assistance, in the last year).
12. Known autoimmune disease, including but not limited to celiac disease, or pre-existing
symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective
13. Previous upper GI surgery, or other endoscopic bariatric procedures or conditions,
prior intra-gastric balloon or another gastric implant.
14. History of diabetic gastroparesis.
15. Known active hepatitis or active liver disease.
16. Acute gastrointestinal illness in the previous 7 days.
17. Known history irritable bowel syndrome, radiation enteritis or other inflammatory
bowel disease, such as Crohn's disease.
18. Known history of a structural or functional disorder of the esophagus that may impede
passage of the device through the gastrointestinal tract or increase risk of
esophageal damage during an endoscopic procedure, including Barrett's esophagus,
esophagitis, dysphagia, achalasia, stricture/stenosis, esophageal varices, esophageal
diverticula, esophageal perforation, or any other disorder of the esophagus.
19. Known history of a structural or functional disorder of the esophagus, including any
swallowing disorder, esophageal chest pain disorders, or drug refractory esophageal
20. Known history of a structural or functional disorder of the stomach including
gastroparesis, gastric ulcer, chronic gastritis, gastric varices, hiatal hernia (>3
cm), cancer or any other disorder of the stomach.
21. Known history of chronic symptoms suggestive of a structural or functional disorder of
the stomach, including any symptoms of chronic upper abdominal pain, chronic nausea,
chronic vomiting, chronic dyspepsia or symptoms suggestive of gastroparesis, including
post-prandial fullness or pain, post-prandial nausea or vomiting or early satiety.
22. Currently have ongoing symptoms suggestive of intermittent small bowel obstruction,
such as recurrent bouts of post-prandial abdominal pain, nausea or vomiting.
23. Active H. pylori infection (Subjects with active H. pylori may continue with the
screening process if they are treated with an appropriate antibiotic regimen, and
eradication has been confirmed).
24. History of coagulopathy, upper gastrointestinal bleeding conditions such as ulcers,
gastric varices, strictures, congenital or acquired intestinal telangiectasia.
25. Current use of anticoagulation therapy
26. Obligate use of anti-inflammatory drugs that cannot be suspended for a minimum of 4
weeks post procedure
27. Use of systemic glucocorticoids (excluding topical or ophthalmic application or
inhaled forms) for more than 10 consecutive days within 90 days prior to the Screening
28. Use of drugs known to affect GI motility (e.g. Metoclopramide).
29. Receiving any weight loss medications such as Meridia, Xenical, Saxenda, Januvia,
Duromine or over the counter weight loss medications at screening.
30. Untreated/inadequately treated hypothyroidism, defined as an elevated
Thyroid-Stimulating Hormone (TSH) level at Screening; if on thyroid hormone
replacement therapy, must be on stable dose for at least 6 weeks prior to Screening.
31. Persistent Anemia, defined as Hemoglobin <10 g/dL.
32. Significant cardiovascular disease including known history of valvular disease, or
myocardial infarction, heart failure, transient ischemic attack or stroke within the
last 6 months.
33. Known moderate or severe chronic kidney disease (CKD), with estimated glomerular
filtration rate (eGFR) <45 ml/min/1.73m2 (estimated by MDRD).
34. Known immunocompromised status, including but not limited to individuals who have
undergone organ transplantation, chemotherapy or radiotherapy within the past 12
months, who have clinically-significant leukopenia, who are positive for the human
immunodeficiency virus (HIV) or whose immune status makes the subject a poor candidate
for clinical trial participation in the opinion of the Investigator.
35. Active systemic infection.
36. Known active malignancy within the last 5 years (with the exception of treated basal
cell or treated squamous cell carcinoma).
37. Subjects with an established diagnosis of Multiple Endocrine Neoplasia syndrome type
38. Not a candidate for surgery or general anesthesia.
39. Active illicit substance abuse or alcoholism.
40. Current smoker or smoking history in the last six months.
41. Participating in another ongoing clinical trial of an investigational drug or device.
42. Any other mental or physical condition which, in the opinion of the investigator,
makes the subject a poor candidate for clinical trial participation.
43. Other medical condition that does not allow for endoscopic procedure.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 6/20/23. Questions regarding updates should be directed to the study team contact.