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 @ 3:58 PM
Ignite Modification Date:
2025-12-24 @ 3:58 PM
NCT ID:
NCT03100292
Eligibility Criteria:
Inclusion Criteria:
1. body mass index (BMI) ≥ 35 kg/m2 or BMI ≥ 30 kg/m2 with co-morbidities such as hypertension, glucose intolerance, dyslipidemia, and sleep apnea
2. being suitable for general anesthesia
3. being able to give informed consent and committed to follow-up
4. Female patients should have a negative urine pregnancy test at screening and agree to use reliable method of contraception for 1 year.
Exclusion Criteria:
1. prior bariatric surgery of any kind
2. being unable to understand the risks, benefits and compliance requirements of this trial
3. pregnancy or planning on being pregnancy
4. non-Korean speaker
5. American society of anesthesiology (ASA) class IV or higher
6. malignancy within 5 years.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
65 Years
Study:
NCT03100292
Study Brief:
Protocol Section:
NCT03100292