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 @ 3:53 PM
Ignite Modification Date:
2025-12-24 @ 3:53 PM
NCT ID:
NCT06794892
Eligibility Criteria:
Eligibility Criteria
Inclusion Criteria:
* Adults aged 18-65 years.
* Experienced insufficient weight loss, defined as:
* Excess weight loss (EWL) \< 50%.
* Total weight loss (TWL) \< 25%.
* BMI \> 40 kg/m² at least two years after primary restrictive surgery.
* Previously underwent laparoscopic sleeve gastrectomy (LSG) or laparoscopic adjustable gastric banding (LAGB).
* Undergoing revisional surgery specifically for inadequate weight loss or weight regain.
Exclusion Criteria:
* Revisional surgery performed for indications other than inadequate weight loss or weight regain (e.g., complications of the primary procedure such as stenosis or refractory gastroesophageal reflux, or for comorbidity management).
* Known psychiatric illness or untreated eating disorders.
* Pregnancy.
* History of prior gastric surgery unrelated to bariatric interventions.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06794892
Study Brief:
Protocol Section:
NCT06794892