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 @ 9:45 PM
Ignite Modification Date:
2025-12-24 @ 9:45 PM
NCT ID:
NCT01564732
Eligibility Criteria:
Inclusion Criteria: Subjects must meet the following criteria to be eligible for study entry:
1. Age between 18-60 years,
2. Morbidly obese:
a. BMI \> 40, or b. BMI \> 35 + co-morbid obesity related disease condition c)BMI \< or equal to 55
Exclusion Criteria: Subjects meeting the following criteria will be excluded from study entry:
1. Patients with any major medical problems contraindicating surgery (eg.myocardial infarct within last 6 months, cancer within last 5 years, end stage renal/liver disease, etc.)
2. Patients with a medically treatable cause of obesity (eg. untreated hypothyroidism, Prader-Willi, etc.)
3. Patients who elect to undergo a surgery other than a PLAGB or SLAGB
4. Patient who is unwilling to be randomized to PLAGB or SLAGB
5. Pregnant or planning pregnancy within 12 months
6. Alcohol or drug addiction
7. Established infection anywhere in the body at the time of surgery
8. Previous history of bariatric surgery, gastric surgery, intestinal obstruction, or adhesive peritonitis.
9. Family or patient history of autoimmune disease
10. Hiatal Hernia \> 3cm (as reported per radiology on pre-operative swallow study)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01564732
Study Brief:
Protocol Section:
NCT01564732