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 @ 7:42 PM
Ignite Modification Date:
2025-12-24 @ 7:42 PM
NCT ID:
NCT04627103
Eligibility Criteria:
Inclusion Criteria:
* Age 19-65 years at screening
* Body mass index (BMI) ≥35 and ≤50
* T2DM diagnosis ≥6 months but \< 10 years, with 1 or more oral diabetes medications, HbA1c ≥ 6.5% but \< 10.0% at time of enrollment.
* HbA1c must be stable over a 3-month period.
* Weight stable over 3-month period
* Obesity-related comorbidities (hypertension, dyslipidemia, sleep apnea) must be well-controlled
* Agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for a duration of 2 years
* If female, subject must commit to not becoming pregnant for 24 months and agree to use contraception during this period
* Able to understand and sign informed consent documents.
Exclusion Criteria:
* Known or suspected allergy to nickel or titanium or nitinol
* Type 1 diabetes or poorly controlled type 2 diabetes
* Use of injectable insulin
* Any documented conditions for which endoscopy would be contraindicated
* Contraindication to general anesthesia
* History of chronic gastrointestinal disease
* Congenial or acquired anomalies of the GI tract
* Any previous major surgery on the stomach, duodenum, hepatobiliary tree (excluding gallbladder), pancreas, or right colon.
* Uncontrolled hypertension
* Pre-existing severe comorbid cardio-respiratory disease
* History of chronic gastrointestinal disease
* Specific genetic or hormonal cause of obesity
* Recent tobacco/nicotine product cessation (within 3 months prior)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
65 Years
Study:
NCT04627103
Study Brief:
Protocol Section:
NCT04627103