Procedure for Duodenum to Ileal Diversion to Treat Type 2 Diabetes
NCT03130244 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2026-04-03
Summary
Study will monitor changes in HbA1c for subjects in Intervention arm vs control arm.
Conditions
Interventions
- 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.
Sponsors & Collaborators
-
GI Windows, Inc.
lead INDUSTRY
Principal Investigators
-
Rudolf H Buxhoeveden · Bariatric Surgeon at Hospital Aleman
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-09-23
- Primary Completion
- 2026-01-15
- Completion
- 2026-04-30
Countries
- Argentina
Study Locations
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