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 @ 12:02 PM
Ignite Modification Date:
2025-12-24 @ 12:02 PM
NCT ID:
NCT06858761
Eligibility Criteria:
Inclusion Criteria:
* Patient aged between 18 and 70 years old,
* Female or male patients
* Patient eligible for one of the two situations defined below:
1. Primary bariatric or metabolic surgery, with a BMI corresponding to one of the 3 following situations, in accordance with the french National Authority for Health (HAS) recommendations published in February 2024:
* 40 kg/m² OR
* 35 kg/m² with at least one comorbidity that may improve after surgery (e.g.: high blood pressure, sleep apnea syndrome and other severe respiratory disorders, type 2 diabetes, disabling osteoarticular diseases, steatohepatitis not alcoholic, dyslipidemia, osteoarthritis) OR between 30 and 35 kg/m² with uncontrolled type 2 diabetes
2. Revision surgery for complication and/or side effects of a previous bariatric surgery
* Patient who has benefited from a pluridisciplinary evaluation (medical, surgical, psychiatric), with a favorable opinion for a bariatric.
* Patient who agrees to be included in the study and who signs the informed consent form,
Exclusion Criteria:
* Presence of a severe and evolutive life threatening pathology, unrelated to obesity,
* Pregnancy or desire to be pregnant during the study,
* Patient not affiliated to a French or European healthcare insurance,
* Patient under supervision or guardianship
* Patient who is unable to give consent,
* Patient who does not understand French
* Patient who has already been included in a trial which has a conflict of interests with the present study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06858761
Study Brief:
Protocol Section:
NCT06858761