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 @ 1:31 AM
Ignite Modification Date:
2025-12-25 @ 1:31 AM
NCT ID:
NCT04165694
Eligibility Criteria:
Inclusion Criteria:
1. Body Mass Index (BMI) 35 - 39 kg/m2 with comorbid conditions; OR
2. BMI 40+ kg/m2 with no comorbidities; AND
3. having a previous laparoscopic sleeve gastrectomy (LGS); AND
4. having lost less than 10% total weight loss with this LSG; AND
5. being a Kaiser member at the time of surgery; AND
6. being at least 18 years of age.
Exclusion Criteria:
1. BMI less than 35 kg/m2; OR
2. having a hiatal hernia; OR
3. having severe Gastroesophageal Reflux Disease; OR
4. having a primary bariatric procedure other than LSG; OR
5. having already had a revisional bariatric procedure; OR
6. being less than 18 years old.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT04165694
Study Brief:
Protocol Section:
NCT04165694