Duodenal-Ileal Diversion + Sleeve Gastrectomy for Obesity and Type 2 Diabetes

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: GI Windows, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?Study will monitor weight loss and metabolic indicators for subjects in multi-center, single arm trial.

Eligibility Criteria

This trial is for adults aged 19-65 with obesity (BMI between 35 and 50) and type 2 diabetes diagnosed within the last decade. Participants must have stable weight, controlled related health issues like hypertension, and not be on insulin or planning pregnancy. They should commit to no other weight-affecting surgeries for two years.

Inclusion Criteria

My obesity-related health issues like high blood pressure, cholesterol problems, or sleep apnea are under control.

I agree not to become pregnant for 24 months and will use birth control.

Your blood sugar levels must stay steady for 3 months.

+6 more

Exclusion Criteria

I have a long-term stomach or intestine disease.

I have a serious heart or lung condition.

I use injectable insulin.

+9 more

Participant Groups

The study tests a Self Forming Magnetic Anastomosis System in a single group of participants across multiple centers. It aims to assess its effect on weight loss and metabolic changes in patients with obesity and type 2 diabetes.

1Treatment groups

Experimental Treatment

Group I: Device PlacementExperimental Treatment1 Intervention

The subjects in this arm will receive the Self-Forming Magnet (SFM) System that will be used to create a duodenal-ileal diversion. Following the diversion creation, a sleeve gastrectomy will also be performed.