Trials / Active Not Recruiting
Active Not RecruitingNCT03130244
Procedure for Duodenum to Ileal Diversion to Treat Type 2 Diabetes
A Trial for a Procedure for Duodenum to Ileal Diversion to Treat Type 2 Diabetes
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- GI Windows, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
Study will monitor changes in HbA1c for subjects in Intervention arm vs control arm.
Detailed description
Randomized, Single-Center, Parallel-group, Open-label Pilot Study to Evaluate the Safety and Effectiveness of the GI Windows Magnet Anastomosis System (MAS) When Used to Create a Dual-path Enteral Diversion Compared with Medical Therapy Alone To Effect Glycemic Control in Obese Patients with Type 2 Diabetes Mellitus (T2DM)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Magnet Anastomosis System | The MAS will be placed using an endoscope in the duodenum and and laparoscopically into ileum. A compression anastomosis will be created in each of the patients and the diversion of enteral flow from the duodenum to ileum treats Type 2 diabetes. |
| DRUG | Best Medical Management | The best medical management for the patients in this arm will be decided by the endocrinologist based on protocol parameters. |
Timeline
- Start date
- 2019-09-23
- Primary completion
- 2026-01-15
- Completion
- 2026-04-30
- First posted
- 2017-04-26
- Last updated
- 2026-04-03
Locations
1 site across 1 country: Argentina
Source: ClinicalTrials.gov record NCT03130244. Inclusion in this directory is not an endorsement.