The purpose of this clinical research study is to evaluate the feasibility of the GT Metabolic Solutions Magnet System, GJ Biofragmentable ("MagGJ System") for creation of a side-to-side anastomosis for gastro-ileal or gastro-jejunal diversion in obese adults.
The purpose of this clinical research study is to evaluate the feasibility of the GT Metabolic Solutions Magnet System, GJ Biofragmentable ("MagGJ System") for creation of a side-to-side anastomosis for gastro-ileal or gastro-jejunal diversion in obese adults. This partial diversion of intestinal contents from the stomach to the ileum or jejunum is intended to facilitate weight management/loss in obese adults and improve metabolic outcomes in obese adults with type 2 diabetes mellitus ("T2DM"). Side-by-side anastomoses are currently created by sutures, staples, and anastomotic compression devices. A predicate procedure is the single anastomosis sleeve ileal (SASI) bypass procedure that includes a gastro-ileostomy at the distal antrum of the stomach. Additionally, the one anastomosis gastric bypass (OAGB) or single anastomosis gastric bypass (SAGB) performed in two stages may also be considered a predicate procedure where an anastomosis between the jejunum and anterior lesser curvature of the stomach is performed, followed by a second stage gastric pouch stapling more than 12 months later (non-study procedure).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Anastomoses achieved by magnetic compression.
Westmount Surgical Center
Westmount, Quebec, Canada
Clinica MEDS La Dehesa SpA
Santiago, Chile
Hospital Lusiadas Amadora
Amadora, Portugal
Cleveland Clinic Abu Dhabi
Abu Dhabi, United Arab Emirates
Magnet Placement
MagGJ System placement ≥ 90% alignment of magnets
Time frame: 1 Day
Natural Magnet Passage
Passage of magnets without surgical re-intervention
Time frame: 30 Days
Anastomosis Patency
Confirmed radiologically or fluoroscopically
Time frame: Day 30
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