NCT04627103

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: GI Windows, Inc. · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Study will monitor weight loss and metabolic indicators for subjects in multi-center, single arm trial.

Detailed description

Multi-Center, Open-label Pilot Study to Evaluate the Safety and Effectiveness of the GI Windows Single Neodymium Magnet Anastomosis Procedure When Used to Create a Duodenal-Ileal Diversion with a Sleeve Gastrectomy (SNAP-S) for Subjects with Obesity and Type 2 Diabetes Mellitus (T2DM)

Conditions

• Obesity
• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Self Forming Magnetic (SFM) Anastomosis System	The SFM will be placed using an endoscope in the duodenum and laparoscopically into the ileum. A compression anastomosis will be created in each of the subjects and the diversion of enteral flow from the duodenum to ileum will create a metabolic effect that will induce weight loss and impact Type 2 Diabetes. Following the diversion being created, a gastric sleeve will be created according to standard technique.

Timeline

• Start date: 2021-10-07
• Primary completion: 2024-07-30
• Completion: 2025-10-30
• First posted: 2020-11-13
• Last updated: 2025-11-20

Locations

2 sites across 1 country: Canada