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 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT02315105
Eligibility Criteria:
Inclusion Criteria:
1. Subject is willing to give consent and comply with evaluation and treatment schedule
2. 18 to 65 years of age
3. Have a BMI \> 30 with one or more significant co-morbid medical conditions which are generally expected to be improved, reversed, or resolved by weight loss. these conditions include but are not limited to:
* Hyperlipidemia
* Type 2 diabetes
* Mild Obstructive Sleep Apnea
* Hypertension
* Osteoarthritis of the hip or knee
4. Agree to refrain from any type of weight-loss drug ( prescription or OTC) or elective procedure that would affect body weight for the duration of the trial
5. HbA1C \< 11 %
6. For subjects who have Type 2 Diabetes, the anti-diabetic medication regimen is no more complex than oral metformin plus one oral sulfonylurea plus once daily insulin injection.
7. Ability to self-pay for the procedure and follow up.
Exclusion Criteria:
\-
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02315105
Study Brief:
Protocol Section:
NCT02315105