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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

Recruiting
18-65 years
Both
Phase N/A

This study is for adults aged 18-65 who have not lost enough weight after certain surgeries for obesity. The study uses a new tool called the **Self-Forming Magnetic (SFM) Anastomosis System**. This tool helps to connect parts of the intestines in two ways: for those with previous **sleeve gastrectomy** (a type of weight loss surgery), it connects the duodenum (part of the small intestine) to the ileum (another part of the small intestine) and for those undergoing **Roux-en-Y gastric bypass** (another weight loss surgery), it connects the jejunum (another part of the small intestine) to itself.

Participants will be evaluated by a team of doctors before the procedure. The study will monitor safety and how well the device works. Participants must live near the study center for 24 months and commit to healthy living.

  • The study lasts for 24 months and you need to live close to the study center.
  • Participants should not smoke and, if female, must not become pregnant during the study.
  • The procedure involves connecting parts of the intestine using a magnetic device.
Study details
    Obesity
    Morbid

NCT06200896

GI Windows, Inc.

10 July 2024

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