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 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT03558360
Eligibility Criteria:
Inclusion Criteria:
* BMI ≥ 40 or BMI ≥ 35 kg/m2 and a complication that can be improved after bariatric surgery: cardiovascular disease including hypertension, severe metabolic disorder including type 2 diabetes, sleep apnea syndrome or other severe respiratory disorder, hepatic steatosis, disabling osteoarticular disease.
* Patient requiring bariatric surgery (sleeve-gastrectomy or gastric bypass)
* Patient who has agreed to participate in the study
* Patient with social security coverage.
Exclusion Criteria:
* Patient with a contraindication to bariatric surgery (cognitive or psychological disorders, severe eating disorders, addiction to alcohol or psychoactive substances, contraindication to general anaesthesia, multiple history of digestive surgery, high risk of undernutrition (progressive cancer, chronic inflammatory bowel disease, cirrhosis, severe renal insufficiency...)
* Pregnant or lactating women
* Minor patient
* Major patient under tutorship, curatorship, or deprived of liberty
* Patient unable to understand protocol and / or give express consent
* Patient not affiliated with a social security system or beneficiary of such a scheme
* Patient participating in an intervention-type clinical research protocol likely to modify the evaluations of this protocol
* adults under the protection of justice
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03558360
Study Brief:
Protocol Section:
NCT03558360