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ACTIVE NOT RECRUITING
NCT06199635
NA

Early Feasibility for Safety & Device Functionality of SFM Anastomosis Device Used in 3 Procedures (SNAP-S) or (SNAP-PS) or (J-J)

Sponsor: GI Windows, Inc.

View on ClinicalTrials.gov

Summary

The objectives of this study are to assess the initial safety and device functionality of the SFM Anastomosis System including delivery systems when used to create a duodenal-ileal (D-I) anastomosis either during sleeve gastrectomy (i.e., SNAP-S procedure) or patients with prior sleeve gastrectomy who experience inadequate weight loss (i.e., SNAP-PS procedure) or a Roux-en-Y gastric bypass jejuno-jejunostomy. Additionally, the study is designed to evaluate the potential of these procedures to induce weight loss and to improve metabolic comorbidities in obese subjects.

Official title: Evaluate the Initial Safety and Device Functionality of the SFM Anastomosis Device for a Primary Sleeve Gastrectomy Duodenal-Ileal Anastomosis (SNAP-S) or After Primary Sleeve Gastrectomy (SNAP-PS) or to Create a Jejuno-Jejunostomy in a Roux-en-Y Gastric Bypass (J-J)

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2023-12-15

Completion Date

2026-03-30

Last Updated

2026-02-17

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Self-Forming Magnetic Anastomosis Device and Delivery System

Self-Forming Magnetic Anastomosis Device to create a gastrointestinal anastomosis

Locations (2)

Clinica Colonial Hospital

Santiago, Huechuraba, Región Metropolitana, Chile

Bhandari Hospital & Research Centre

Indore, Madhya Pradesh, India