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 @ 2:16 PM
Ignite Modification Date:
2025-12-24 @ 2:16 PM
NCT ID:
NCT02072395
Eligibility Criteria:
Inclusion Criteria:
* Age 18-70
* BMI \> or = to 30 and co-morbid conditions or BMI \> or = to 40
* Ability to provide informed consent
* Willingness to commit to long-term follow-up
Exclusion Criteria:
* Inability to provide informed consent
* Presence of metabolic or medically correctable cause(s) for obesity, such as untreated hypothyroidism or Prader-Willi
* Contraindications to surgery such as myocardial infarction within last 6 months, end stage renal or liver disease, current infection, or other disease states contraindicative to surgery, in the principal investigator's opinion
* Pregnancy
* Plan to become pregnant within two years post-surgery
* Current addiction to drugs or alcohol
* Previous history of any type of bariatric surgery (de novo group only)
* Hiatal hernia \> 3 cm
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02072395
Study Brief:
Protocol Section:
NCT02072395