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 @ 10:40 PM
Ignite Modification Date:
2025-12-24 @ 10:40 PM
NCT ID:
NCT04800835
Eligibility Criteria:
Inclusion Criteria:
1. Have a BMI ≥ 27
2. Be male or female, between 18 and 65 years of age, inclusive;
3. Have a history of excess weight (BMI ≥ 27 kg/m2) for at least 2 years and have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavioral modification programs;
4. Be willing to commit to a long-term low calorie (1000-1500 calories/day) supervised diet;
5. Have reasonable weight loss expectations (accept a goal of losing up to 15% of body weight after 52 weeks);
6. Be able to follow requirements outlined in the protocol, including complying with the visit schedule and behavioral modification program, and willing to undergo protocol-specific procedures, e.g., endoscopy, local sedation, general anesthesia, upper gastrointestinal radiography (UGI), electrocardiography (EKG), gastric motility testing, and/or clinical laboratory testing, and must be willing to take prescribed proton pump inhibitors (PPIs);
7. Be able to provide written informed consent;
8. supporting that the subject is an appropriate study candidate;
9. Be willing to use contraception (e.g., birth control pills, condoms, abstinence) and avoid pregnancy during the study if female of child-bearing potential.
Exclusion Criteria:
1. Previous history of esophageal, gastric or duodenal surgery, any bariatric surgery, any hiatal hernia surgery, bowel obstruction surgery, adhesive peritonitis, and/or hiatal hernia \> 4 cm;
2. A history of myocardial infarction in the previous 6 months: New York Heart Associate (NYHA) Class III or IV (heart failure) or cardiac arrhythmia (e.g. atrial fibrillation);
3. History or symptoms of varices, bowel obstruction, congenital or acquired GI anomalies (e.g., atresias, stenosis, stricture, and/or diverticula), severe renal, hepatic, and/or pulmonary disease;
4. History or symptoms of inflammatory bowel disease, such as Crohn's disease;
5. History of unstable thyroid disease;
6. History of uncontrolled gastro-esophageal reflux;
7. Type I diabetes;
8. History of dysphagia, esophageal stricture or esophageal food impaction;
9. Poor general health, in the opinion of the Placing and/or Evaluating Investigator, or presence of a specific medical condition that would increase the risks associated with endoscopy and/or placement of the device;
10. Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease.
11. Pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD);
12. Specific diagnosed genetic or hormonal cause for obesity such as Prader Willi syndrome;
13. History or symptoms of esophageal or GI motility disorders (e.g., gastroparesis, achalasia, diffuse esophageal spasm) or symptoms of esophageal stricture;
14. Ongoing treatment with anticoagulants, steroids, aspirin \> 100 mg, non-steroidal anti- inflammatory drugs (NSAIDS), or other medications known to be gastric irritants, and inability or unwillingness to discontinue the use of these concomitant medications;
15. Evidence of untreated psychiatric or eating disorders, such as major depression, schizophrenia, substance abuse;
16. Pregnancy, breast-feeding, or intention of becoming pregnant during the study (if female of childbearing potential);
17. A condition, or is in a situation, which in the Evaluating and/or Placing Investigator's opinion may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04800835
Study Brief:
Protocol Section:
NCT04800835