Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions DI Biofragmenta… (NCT07085741) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions DI Biofragmentable Magnetic Anastomosis System in Mexico
Mexico10 participantsStarted 2025-05-07
Plain-language summary
The purpose of this clinical research study is to evaluate the feasibility / performance, safety and initial efficacy of the GT Metabolic Solutions DI Biofragmentable Magnetic Anastomosis System (MAGNET System, DI Biofragmentable) for creation of a side-to-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 30-34.9 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.