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 @ 4:56 PM
Ignite Modification Date:
2025-12-24 @ 4:56 PM
NCT ID:
NCT01249950
Eligibility Criteria:
Inclusion Criteria:
* failure of weight loss in an organized care\> 6 months
* BMI \> à 35 kg/m2 with presence of severe co-morbidities (diabetes, moderate or severe OSAS, intracranial hypertension, severe hepatic steatosis), which can be improved by a significant weight loss and sustainable OR BMI \> or = 40 kg/m2 with less severe co-morbidities (hypertension, GERD) and may worsen the health status including reduced quality of life.
* Patients must have completed their growth (bone age \> 13 for girls and \>15 for boys).
* The teenager and his legal representative must have given their informed consent.
* The subject must be affiliated to a social security scheme
Exclusion Criteria:
* syndromic obesities
* tumor-induced obesity
* Patient with severe psychiatric disorders
* Patient with eating disorders
* Patients under judicial protection
* Patient under guardianship or curatorship
* Patient participating in another study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
18 Years
Study:
NCT01249950
Study Brief:
Protocol Section:
NCT01249950