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 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT00394212
Eligibility Criteria:
Inclusion Criteria:
* 6 months post primary RYGB with inadequate weight loss or weight regain
* BMI \>30 and ≤ 50
* Dilated gastrojejunal anastomosis
* Successfully completes screening process
* Signed consent
Exclusion Criteria:
* Recently quit smoking or plan to quit within the next year
* Pregnant or planning to become pregnant over the course of the next 9 months
* Mallampati score of 4
* Serious systemic disease or active disease of the gastrointestinal tract
* Gastric pouch abnormalities
* Significant movement limitations
* Use of weight-promoting or weight-reduction drugs during study period
* Severe eating disorders
* Uncontrolled depression or psychoses
* Ongoing severe complication resulting from initial RYGB or other condition that in the investigators' assessment would make the patient an unsuitable candidate for the study procedure
* History of significant cardiovascular, cerebrovascular or pulmonary disease
* Not a candidate for conscious or general sedation
* Anticoagulant therapies
* Active substance abuse
* Life expectancy \< 1 year
* Enrolled in another investigational drug or device trial that has not completed the primary endpoint or that clinically interferes with this trial's study endpoints
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00394212
Study Brief:
Protocol Section:
NCT00394212