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.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions Magnetic Anastomosis System (The MAGNET System) to Achieve Duodeno-Ileostomy Diversion.
CHU St Pierre
Brussels, Belgium
Westmount Surgical Center
Westmount, Quebec, Canada
Innova Medical Center
Tbilisi, Georgia
Hospital Clinico San Carlos Complutense University of Madrid
Madrid, Spain
Feasibility and performance measured by anastomosis success
The primary feasibility/performance endpoint is the feasibility/performance of side-to-side anastomosis duodeno-ileostomy defined as: * Placement of the MAGNET System (≥ 90% alignment of magnets); and * Passage of magnets without surgical re-intervention; and * Creation of a patent anastomosis, confirmed radiologically. The primary endpoint will be met if the feasibility/performance is confirmed in ≥ 80% of enrolled and treated subjects.
Time frame: Day 90
To evaluate the safety of the MAGNET System
The incidence of treatment emergent AEs and SAEs is a standard measure of the safety. The incidence of device malfunction informs about the device reliability.
Time frame: Day 30, 90, 180, and 360
Efficacy of weight loss
Efficacy will be assessed at Day 90, 180 and 360 based on change from baseline in total weight loss and excess weight loss (EWL)
Time frame: Day 90, 180, and 360
Efficacy of metabolic improvement
Efficacy will be assessed at Day 90, 180 and 360 based on change from baseline in functional improvement of metabolic indicators (HbA1c, blood glucose)
Time frame: Day 90, 180, and 360
Quality of life improvement
Efficacy will be assessed at Day 90, 180 and 360 based on change from baseline in quality of life improvement (SF-36)
Time frame: Day 90, 180, and 360
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