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:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT02048033
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18 years
* Surgical criteria: patient with bariatric surgery by gastric bypass since, at least, 24 months
* Clinics criteria of weight regain or treatment failure:
* Patient with weight regain\> 5kg / m²
* Patient with EWL (excess weight loss) \<25% after 2 years of treatment.
* Loss of early satiety (interrogation)
* Patient with a compatible psychological and cognitive status with the study,
* Patient agreeing to follow the procedures of the study and can participate at the follow-up study during 2 years
* Subject with no rights from the national health insurance programme
* Consent form signed
Exclusion criteria:
* Pregnancy (plasma assay of beta-HCG positive)
* Presence of cardiovascular, neurological, psychiatric, endocrine, renal, gastrointestinal or tumor comorbidities making irrelevant patient participation in the judgment of the investigator
* Patient participating in another clinical study or participated in another study within the last 30 days or for which the annual compensation received exceeds € 4,500
* Patient with a contre-indication to the achievement of surgery (fistula, ulceration, ...)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02048033
Study Brief:
Protocol Section:
NCT02048033