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 @ 11:20 PM
Ignite Modification Date:
2025-12-24 @ 11:20 PM
NCT ID:
NCT07004556
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 18-65 years.
* Patients with severe obesity (Body Mass Index (BMI) ≥ 40 kg/m²) with no additional comorbidities (Type III, Type IV, and Type V obesity) who are scheduled for primary LSG.
* Patients who consent to participate in the study.
Exclusion Criteria:
* Patients who do not consent to participate in the study.
* Patients scheduled for primary obesity surgery other than LSG (e.g., Single Anastomosis Gastric Bypass, Roux-en-Y Gastric Bypass, Transit Bipartition, Single Anastomosis Sleeve Ileal Bypass, Single Anastomosis Duodeno-intestinal Bypass, Duodenal Switch).
* Patients with a BMI ≥ 35 kg/m² with associated medical problems (e.g., Diabetes Mellitus, Asthma, Chronic Obstructive Pulmonary Disease, Ischemic Heart Disease, Hypertension).
* Patients with a BMI ≤ 35 kg/m² who do not have a surgical indication.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07004556
Study Brief:
Protocol Section:
NCT07004556