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 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT04942093
Eligibility Criteria:
Inclusion Criteria:
* Patient eligible for bariatric surgery (according to HAS criteria) whose sleeve gastrectomy is scheduled
* Patient with morbid obesity (BMI ≥ 40)
* Age ≥ 18 years and ≤ 65 years
* Haemoglobinemia ≥ 12 g/dL in men and ≥ 11 g/dL in women
* Patient speaking and understanding French
* Adult having read and understood the information letter and signed the consent form
* Woman of childbearing age with effective / very effective contraception (Cf. CTFG) (estrogen-progestin or intrauterine device or tubal ligation) prior to surgery and a negative -HCG blood pregnancy test at inclusion, for the duration of the study
* Postmenopausal woman: confirmatory diagnosis (non-medically induced amenorrhoea for at least 12 months prior to the inclusion visit)
* Patient affiliated with, or beneficiary of a social security (health insurance) category
Exclusion Criteria:
* Contraindication to bariatric surgery detected during the preoperative assessment
* Medical contraindication to a restrictive diet
* Type I or II insulin-requiring diabetes
* Severe renal insufficiency defined by a blood filtration rate \< 30 mL/min
* Person wearing a pacemaker or any other implant with the same functions (cochlear implant, bladder battery, etc.)
* Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection / sub-guardianship or curatorship
* A history of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol or to prevent him/her from giving informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04942093
Study Brief:
Protocol Section:
NCT04942093