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Early Feasibility Study: Assessment of Self-Forming Magnetic Anastomosis Device and Delivery System (SFM) in Obese Patients, When Used to Create a Duodenal-Ileal Anastomosis Post SG (SNAP-PS), or When Used to Create a Jejuno-Jejunal (J-J) Anastomosis

Exploring a new device for stomach connections in obese patients.

Recruiting
18-65 years
All
Phase N/A
This study tests a **new device** called the Self-Forming Magnetic Anastomosis Device. This device helps connect parts of the intestine without stitches. It’s being tested on people who had weight-loss surgery but didn’t lose enough weight. The study includes two types of surgeries: **SNAP-PS** (for those with a sleeve gastrectomy) and **J-J** (for those with a Roux-en-Y gastric bypass). Key Points: - The study lasts for **24 months**, and participants must live close to the study center. - Participants need to commit to a **healthy lifestyle**, including diet and exercise. - Women must avoid getting pregnant and use birth control during the study. The study is for people aged 18-65 with a Body Mass Index (BMI) of 40-55 for the SNAP-PS group and 35.1-50 for the J-J group. Participants should not have conditions like **Type 1 Diabetes** or **uncontrolled hypertension**. They must also abstain from smoking and live within a 150-km radius of the study center. This is an opportunity to try a new medical device, but it involves risks, such as the possibility of not losing weight or needing additional procedures.
Study details
    Obesity
    Morbid

NCT06200896

GI Windows, Inc.

10 July 2024

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