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:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07449520
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 18 to 75 years.
* Patients with a Body Mass Index (BMI) ≥ 30 kg/m².
* Patients who have failed non-surgical weight loss interventions (diet, exercise, pharmacological therapy).
* Patients not eligible for bariatric surgery or does not wish to undergo it.
* Patients who can undergo general anesthesia.
* Patients who are able to participate in all aspects of the study and agree to comply with all study requirements for the entire duration of the study.
* Patients who are able to fully understand the study and are willing to give their consent to participate in the study.
* Patients affiliated with the French social security system.
Exclusion Criteria:
* Patients with contraindications to endoscopic gastroplasty
* Patients with active peptic ulcer disease or significant gastroparesis
* Patients with a history of bariatric, gastric, or esophageal surgery.
* Patients who have started medication in the last 3 months that is known to cause weight gain.
* Patients with a history of uncontrolled, poorly controlled, or suspected eating disorders or psychiatric illness.
* Patients with unstable and precarious health, as determined and assessed by the investigator.
* Patients who are pregnant, breastfeeding, or of childbearing age and not using effective contraception.
* Patients who are currently excluded (as determined by a previous or ongoing study).
* Patients under judicial protection.
* Patients under guardianship, conservatorship or subject to any form of protective supervision
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07449520
Study Brief:
Protocol Section:
NCT07449520