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:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-26 @ 5:23 PM
NCT ID:
NCT01829906
Eligibility Criteria:
Inclusion Criteria:
* Body mass index (BMI) \>40kg/m2, or BMI\>35kg/m2 with comorbidities
* healthy volunteers with suboptimal weight loss
* health with significant weight regain after Roux-n-Y Gastric Bypass, defined as failure to lose at least 40% Excess Weight Loss by 12 months postoperatively.
Significant weight regain: Regain of ≥15% of total weight lost after the first postoperative year.
Exclusion Criteria:
* Pregnancy
* enrollment in another obesity treatment
* previous revisional bariatric surgery
* planned bariatric surgery
* past or ongoing drug or alcohol abuse
* physical or mental impairment that interferes with the ability to comply to treatment
* history of severe psychological disorder
* history of severe eating disorder
* current medication known to affect appetite or induce weight loss
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01829906
Study Brief:
Protocol Section:
NCT01829906