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 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT02409160
Eligibility Criteria:
Inclusion Criteria:
1. Patients eligible for the trial must comply with all of the following at randomization:
2. male and female patients aged 18 to 65 years,
3. grade III severe obesity (BMI ≥ 40 kg/m2) or ≥ 35 kg/m2 with comorbidities,
4. awaiting bariatric surgery,
5. with documented history of conventional weight loss attempts having proven unsuccessful over time,
6. and if they are able to understand and agreement to participate in the study through a signed term of informed consent.
Exclusion Criteria:
1. Any medical condition rendering surgery too risky;
2. BMI above 55 kg/m2;
3. Unrealistic postoperative target weight and/or unrealistic expectations of surgical treatment;
4. Pregnancy, lactation or planned pregnancy within two years of potential surgical treatment;
5. Lack of safe access to abdominal cavity or gastrointestinal tract;
6. Abusive alcohol use or drug use.
7. Cancer
8. Any cardiorespiratory condition opposite indicate the surgical procedure.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02409160
Study Brief:
Protocol Section:
NCT02409160