NCT05322122

Creation of Side-to-Side Compression Anastomosis Using the Magnetic Anastomosis System

Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions Magnetic Anastomosis System (MAGNET System) to Achieve Duodeno-Ileostomy Diversion in Adults With Obesity and With or Without Type 2 Diabetes Mellitus

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: GT Metabolic Solutions, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is an operationally seamless, open-label, multicenter study enrolling up to 50 subjects with obesity and with or without type 2 diabetes at up to 5 study centers across Canada and Europe who will undergo sleeve gastrectomy (revision or de novo) with side-to-side anastomosis duodeno-ileostomy using the MAGNET System and will be followed for 12 months.

Detailed description

The MAGNET study is an operationally seamless, 2-stage, open-label, multicenter study enrolling up to 50 subjects at up to 5 study centers across Canada and Europe as follows: * Stage 1 first-in-human (FIH) and proof-of-concept with 5 subjects; and * Stage 2 feasibility with 45 subjects. There will be a pause after completing enrollment in Stage 1 to allow completion of Day 30 and evaluation of safety by the independent Data Safety Monitoring Committee (DSMB). The DSMB will confirm whether the study can advance to Stage 2. All subjects in Stage 1 and 2 will be followed for 12 months. Study Procedure: Side-to-side anastomosis duodeno-ileostomy diversion procedure using the MAGNET System Study Population: Adults (18 to 65 years of age, inclusive) with obesity (BMI 30-50) who meet one of the following criteria: (1) have type 2 diabetes mellitus (T2DM) or experienced weight regain following previous sleeve gastrectomy; (2) have T2DM without previous sleeve gastrectomy; or (3) are candidates for a laparoscopic single anastomosis duodenal-ileal bypass with sleeve (SADI-S) procedure and have BMI ≥ 40. Follow-up: Each subject will return for 6 follow-up visits at Day 14, 30, 60, 90, 180, 270 and 360 (end of study).

Conditions

• Obesity

Interventions

Type	Name	Description
DEVICE	Side-to-side anastomosis duodeno-ileostomy diversion procedure	Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions Magnetic Anastomosis System (The MAGNET System) to Achieve Duodeno-Ileostomy Diversion.

Timeline

• Start date: 2021-11-18
• Primary completion: 2023-06-22
• Completion: 2024-04-04
• First posted: 2022-04-11
• Last updated: 2024-06-21

Locations

4 sites across 4 countries: Belgium, Canada, Georgia, Spain