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 @ 2:50 AM
Ignite Modification Date:
2025-12-25 @ 2:50 AM
NCT ID:
NCT05307133
Eligibility Criteria:
Inclusion Criteria:
* Women aged 18-65, pre-menopausal,
* able to read and understand the written informed consent,
* with a BMI \> 40 or 35
* with at least one obesity linked comorbidity among blood hypertension,
* type 2 diabetes,
* sleep apnea syndrome,
* invalidating arthritis,
* indication for sleeve gastrectomy
* accepted by the multidisciplinary committee and the CPAM (local health care system agency),
* affiliation to the Fre,nch health care system,
* signature of the informed consent.
Exclusion Criteria:
* Post-menopausal women,
* any other bariatric procedure that sleeve gastrectomy, history of any other bariatric procedure,
* pregnancy,
* age less than 18 years under, under guardianship
* Patients undergoing any other procedure that the planned sleeve gastrectomy or undergoing a second bariatric procedure for a complications during the 6 months follow-up.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05307133
Study Brief:
Protocol Section:
NCT05307133