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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

Study on a new device for digestive surgery in obese patients.

Recruiting
18-65 years
All
Phase N/A
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study explores a new device, the **Self-Forming Magnetic Anastomosis (SFM)** System, which helps connect parts of the intestines. This is useful for people who haven't lost enough weight after a surgery called **sleeve gastrectomy**, or for those having a **Roux-en-Y gastric bypass**. The goal is to see how safe and effective the device is. Participants will be adults aged 18-65 years who meet certain health criteria and live near the study center for the next two years. They must agree to maintain healthy habits and, if female, avoid pregnancy during the study.

  • Participants will undergo a procedure to test the SFM device.
  • The study takes place over 24 months with follow-up visits.
  • Participants must commit to healthy lifestyle changes and staying close to the study location.

Note: People with specific allergies, uncontrolled diabetes, or certain health conditions cannot join. The study ensures a comprehensive evaluation including medical and psychological assessments.

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Study details
    Obesity
    Morbid

NCT06200896

GI Windows, Inc.

10 July 2024

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