Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2025-12-24 @ 1:12 PM
NCT ID:
NCT04773795
Eligibility Criteria:
Inclusion Criteria:
1. Age 21-70
2. BMI ≥ 30 and ≤40 kg/m².
3. Willingness to comply with the substantial behavioral modifications program as required by the procedure.
4. Patients with 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, completing IWQOL questionnaire and completing the medically supervised diet and behavior modification program.
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.
Exclusion Criteria:
1. Prior surgery of any kind on the gastrointestinal tract (except uncomplicated cholecystectomy or appendectomy).
2. Patients with history of small bowel or colonic obstruction, and/or adhesive peritonitis and/or abdominal adhesions.
3. Patients with any inflammatory disease
4. Patients with history of cancer in the gastrointestinal tract.
5. Potential upper gastrointestinal bleeding conditions such as a history of angioectasias.
6. A known gastric mass or gastric polyps \> 1 cm in size.
7. Patients with TG \>500 or LDL \>190
8. A known hiatal hernia \> 4cm of axial displacement of the z-line above the diaphragm or severe or intractable gastro-esophageal reflux symptoms while on maximal medical therapy.
9. A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the endoscope.
10. Patient with motility disorders of the GI tract or intractable constipation
11. Patients with known coagulation disorder (INR \>1.5) or on anticoagulation therapy.
12. Type 1 diabetes or Type 2 diabetes with a HgbA1c \>8 in 6 weeks prior the procedure or use of any medication for diabetes other than metformin. Patients with any serious health condition unrelated to their weight that would increase the risk of endoscopy
13. Patients with chronic abdominal pain
14. Patients with hepatic insufficiency or cirrhosis
15. Patients that used an intragastric device for weight loss within 2 years prior to this study.
16. Patients with psychological health questionnaire-9 (PHQ-9) score of 10 or higher.
17. Patients receiving daily prescribed treatment with high dose aspirin (\> 100mg daily), anti-inflammatory agents, anticoagulants or other gastric irritants.
18. Patients with history or current abuse of drugs or alcohol
19. Patients who are unable or unwilling to take prescribed proton pump inhibitor medication
20. egg, milk, or wheat allergy (unable to go through the GEBT)
21. Patients who are pregnant or breast-feeding.
22. Patients who are taking medications that cause weight loss
23. Patients with Severe cardiopulmonary disease or other serious organic disease which might include known history of coronary artery disease, Myocardial infarction within the past 12 months, poorly-controlled hypertension, required use of NSAIDs
24. Patients taking medications on specified hourly intervals that may be affected by changes to gastric emptying, such as anti-seizure or anti-arrhythmic medications
25. Patients who are taking corticosteroids, immunosuppressants, and narcotics
26. Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease.
27. Pre-existing respiratory disease such as chronic obstructive pulmonary disease (severe COPD), pneumonia or cancer.
28. Diagnosis of autoimmune connective tissue disorder (e.g. lupus, HIV, erythematous, scleroderma) or immunocompromised.
29. Specific diagnosed genetic disorder such as Prader Willi syndrome (motility disorder)
30. Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating
31. Known history of endocrine disorders affecting weight such as uncontrolled hypothyroidism.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
70 Years
Study:
NCT04773795
Study Brief:
Protocol Section:
NCT04773795