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 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT03206905
Eligibility Criteria:
Inclusion Criteria:
* BMI greater than or equal to 40 kg/m2, greater than or equal to to 30 kg/m2 with 1 more obesity related co-morbidity, or or greater than or equal to 35 kg/m2 without co-morbidity
Co-morbidities include:
1. Sleep apnea (STOP-BANG questionnaire and polysomnography)
2. BP \>130/80 or on hypertension meds.
3. A1c \> or = to 5.7, fasting \>100 OR RANDOM \>126, exclude 6.5 and above
4. Waist circumference \>102, or 40 inches if male or \>80 cm 35 inches if female
5. Metabolic syndrome (3 criteria, blood pressure, waist circumference, triglycerides \> 150 or HDL \< 50/40)
* Failure to respond to non-invasive weight loss management for at least 6 months.
* Valid health insurance to cover the cost of procedure and standard of care pre-and post-procedure management/workup.
Exclusion Criteria:
* Untreated endocrine diseases (diabetes, thyroid disorder, pituitary disorder, and sex gland disorder).
* diabetes or A1c \>6.5
* Heart Disease, for example, arrhythmia, heart failure, myocardial infarction.
* Kidney disease with serum creatinine greater than 2.5 mg/dl.
* Cerebrovascular disease, for example, stroke or otherwise unable to exercise.
* Any pregnant or lactating women or who have had childbirth within 6 months.
* Any patients on retinoid therapy or undergoing retinoid therapy that will not last throughout the length of the trial.
* Patients with significant psychiatric disorder.
* Any other chronic condition deemed unsuitable to undergo either arm of the trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03206905
Study Brief:
Protocol Section:
NCT03206905