MagDI Diversion Feasibility Study (NCT05692518) | Clinical Trial Compass
CompletedNot Applicable
MagDI Diversion Feasibility Study
Georgia15 participantsStarted 2022-12-19
Plain-language summary
The purpose of this clinical research study is to evaluate the feasibility of the GT Metabolic Solutions DI Bio-fragmentable Magnetic Anastomosis System (MAGNET System, DI Bio-fragmentable) for creation of a side-by-side anastomosis duodeno-ileostomy in obese adults.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 18-65 years of age, inclusive, at the time of informed consent
✓. BMI 30-35 kg/m2
✓. Type 2 diabetes mellitus (T2DM), defined as HbA1c \> 6.5%, without previous sleeve gastrectomy, and without plan to perform a concurrent sleeve gastrectomy.
✓. Agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for the duration of the study
✓. If a child-bearing female, subject must commit to not becoming pregnant and agree to use contraception for the duration of the study
✓. Willing and able to comply with protocol requirements
Exclusion criteria
✕. Type 1 diabetes
✕. Use of injectable insulin
✕. Uncontrolled T2DM
✕. Previous sleeve gastrectomy procedure or plan to perform a sleeve gastrectomy with the duodeno-ileal anastomosis procedure
✕. Uncontrolled hypertension, dyslipidemia or sleep apnea
✕. Prior intestinal, colonic or duodenal surgery, other than bariatric
✕. Prior surgery, trauma, prostheses, disease or genetic expression which prevent or contra-indicate the procedure, including scarring and abnormal anatomy.