NCT04627103Completed
Procedure for Duodenal-Ileal Diversion With a Sleeve Gastrectomy for Patients With Obesity and Type 2 Diabetes Mellitus
A Trial for a Procedure for Duodenal-Ileal Diversion With a Sleeve Gastrectomy for Patients With Obesity and Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov · Last updated 20 Nov 2025
Brief summary (registry, in English)
Study will monitor weight loss and metabolic indicators for subjects in multi-center, single arm trial.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 18 (actual)
- First submitted
- 2 Nov 2020
- Start date
- 7 Oct 2021
- Primary completion date
- 30 Jul 2024
- Lead sponsor
- GI Windows, Inc.
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT04627103
What you commit to
- Study type: Interventional
- Participants enrolled: 18
- From 7 Oct 2021 to the primary completion date, 30 Jul 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any previous major surgery on the stomach, duodenum, hepatobiliary tree (excluding gallbladder), pancreas, or right colon.
- Recent tobacco/nicotine product cessation (within 3 months prior)
Other illness
- Known or suspected allergy to nickel or titanium or nitinol
- Type 1 diabetes or poorly controlled type 2 diabetes
- Any documented conditions for which endoscopy would be contraindicated
- History of chronic gastrointestinal disease
- Uncontrolled hypertension
- Pre-existing severe comorbid cardio-respiratory disease
- History of chronic gastrointestinal disease
Other
- Use of injectable insulin
- Contraindication to general anesthesia
- Congenial or acquired anomalies of the GI tract
- Specific genetic or hormonal cause of obesity
Who the study is looking for
- 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.
Age in the registry: 19 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| QEII Health Sciences Centre Coordinator of this site? Confirm its status | Halifax | Canada | Unknown status |
| Universite Laval Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.