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 @ 2:29 AM
Ignite Modification Date:
2025-12-25 @ 2:29 AM
NCT ID:
NCT06183034
Eligibility Criteria:
Inclusion Criteria:
* BMI greater than or equal to 50 kg/m2
* Eligible and approved for sleeve gastrectomy as primary bariatric treatment (eligibility and approval for sleeve gastrectomy will be determined from a surgical standpoint by the surgeon)
* Able and willing to sign an Informed Consent document
Exclusion Criteria:
* Qualified for Roux-en-Y gastric bypass
* On FDA-approved weight loss medications at time of consult
* Are lactose intolerant
* History of Type 1 diabetes
* Have had lap band or other prior bariatric surgery
* Global functioning score (GFR) ≤45 mL/min/1.73 m² (this is assessed as a part of the routine procedure for all patients)
* \>70 years old (our program does surgery on very few patients over this age)
* Weight is above 300 kgs (\~660 lbs.). (The weight limit for SECA scales is 300 kgs maximum).
* Have been diagnosed with end stage renal disease (CKD stage 3-5) and on dialysis
* Severe depression measured by Beck Depression Inventory (BDI) (BDI score greater than or equal to 30)
* History of severe psychiatric disorder (schizophrenia, schizoaffective, or bipolar disorder)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06183034
Study Brief:
Protocol Section:
NCT06183034