NCT05049824

Procedure for Duodenal-Ileal Diversion for Patients With Weight Regain Following Sleeve Gastrectomy

Single Neodymium Magnet Anastomosis Procedure When Used to Create a Duodenal-Ileal Diversion for Subjects With Inadequate Weight Loss or Weight Regain Following Sleeve Gastrectomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: GI Windows, Inc. · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Study will monitor weight loss and metabolic indicators for subjects in single-center, single arm trial.

Detailed description

Single-Center, Open-label Pilot Study to Evaluate the Safety and Effectiveness of the GI Windows Single Neodymium Magnet Anastomosis Procedure When Used to Create a Duodenal-Ileal Diversion for Subjects with Inadequate Weight Loss or Weight Regain Following Sleeve Gastrectomy.

Conditions

• Obesity, Morbid

Interventions

Type	Name	Description
DEVICE	Self Forming Magnetic (SFM) Anastomosis System	The SFM will be placed using an endoscope in the duodenum and laparoscopically into the ileum. A compression anastomosis will be created in each of the subjects and the diversion of enteral flow from the duodenum to ileum will create a metabolic effect that will induce weight loss and impact metabolic disease indicators

Timeline

• Start date: 2021-10-26
• Primary completion: 2023-07-25
• Completion: 2024-10-01
• First posted: 2021-09-20
• Last updated: 2024-10-15

Locations

1 site across 1 country: Spain