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 @ 7:22 PM
Ignite Modification Date:
2025-12-24 @ 7:22 PM
NCT ID:
NCT02333903
Eligibility Criteria:
Inclusion Criteria:
* BMI \>40 kg/m² or BMI\>35kg/m² with comorbidities qualifying for bariatric surgery
* Stable obesity or obesity evolving for more than 5 years
* Patient cleared by the surgeon for sleeve gastrectomy one month before recruitment
* Absence of contraindication for a sub-maximal stress test
* Performance of a polysomnography before surgery
* Signed informed consent
* Patient benefiting from Health Care Coverage
Exclusion Criteria:
* Absence of preliminary and regular medical check-ups mandatory before sleeve gastrectomy
* Anticipated difficulty for patient follow-up
* Mental diseases (psychosis, depression, suicidal behavior or history)
* Eating disorders
* Lack of informed consent or cooperation
* Unsufficient patient commitment
* Patient under judiciary protection
* Patient not able to comply with any or all the research procedures over time including physical activity
* Patient excluded from the french database of volunteers for clinical trials
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
25 Years
Maximum Age:
45 Years
Study:
NCT02333903
Study Brief:
Protocol Section:
NCT02333903