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 @ 9:17 PM
Ignite Modification Date:
2025-12-24 @ 9:17 PM
NCT ID:
NCT04282304
Eligibility Criteria:
Inclusion Criteria:
* Patient with a BMI (Body Mass Index) of 40 or BMI of 35 with associated comorbidity and who desires obesity surgery
* Patient agreeing to participate in the study, including the 2 years follow-up
* Patient accepting the constraints of the study related to the group to which he/she will be assigned as a result of randomization (availability to his work, his family, etc.)
* Patient able to receive and to understand the study information and to give written informed consent
* Patient affiliated with the French social security system
Exclusion Criteria:
* Patient with a BMI of more than 60
* Patient with contraindication to laparoscopic obesity surgery
* Patient already operated on for obesity
* Patient with a history of major abdominal surgery
* Patient with contraindications to MRI:
* pace maker or automatic defibrillator, implanted insulin pump
* auditory neurostimulator, anal neurostimulator, etc.
* ferromagnetic bodies in soft tissues, intraocular foreign bodies, cerebral vascular clips
* claustrophobia
* morphotype not allowing access to MRI: morbid obesity with waist circumference greater than 150 cm, shoulder width greater than 59 cm
* Patient with psychiatric pathology (untreated psychosis, drug dependence, etc.)
* Pregnant or breast-feeding patient
* Patient in periods of exclusion (determined by a previous or ongoing study)
* Patient under safeguard of justice
* Patient under guardianship
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04282304
Study Brief:
Protocol Section:
NCT04282304