NCT06199635

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

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)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: GI Windows, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multi-arm, single-center, early feasibility study to evaluate the use of the SFM Anastomosis System for creation of a Duodenal-ileal anastomosis in participants undergoing primary sleeve gastrectomy (SNAP-S cohort) or who have experienced inadequate weight loss following sleeve gastrectomy (SNAP-PS cohort) defined to be failure to achieve a minimum 50% EWL at least 18 months post sleeve gastrectomy or creating the jejuno-jejunostomy anastomosis in a Roux-en-Y gastric bypass. Adult male and female subjects between the ages of 18 and 65 years-old who are candidates for the primary or revisional surgery will be considered for participation. Patients appearing to meet basic eligibility criteria and who sign the study specific consent form will be screened for enrollment into this study and will be assessed by a multidisciplinary research team with pre-procedure nutritional and medical evaluation (including psychological and behavioral evaluation by an internist/bariatrician). Subjects meeting the inclusion and exclusion criteria and enrolled into the study will undergo a procedure using the SFM anastomosis device in which the duodenum will be connected to the ileum with the creation of an anastomosis using the SFM device and delivery systems. For subjects undergoing concurrent sleeve gastrectomy and D-I anastomosis (SNAP-S cohort) it is anticipated that the D-I diversion will be created after the sleeve gastrectomy (unless the investigator determines that the reverse order is more appropriate for a particular subject). For subjects undergoing a Roux-en-Y gastric bypass, the standard surgical protocol will be followed at the institution coupled with the minor changes required to connect the SFM device.

Conditions

• Morbid Obesity

Interventions

Type	Name	Description
DEVICE	Self-Forming Magnetic Anastomosis Device and Delivery System	Self-Forming Magnetic Anastomosis Device to create a gastrointestinal anastomosis

Timeline

• Start date: 2023-12-15
• Primary completion: 2025-01-15
• Completion: 2026-03-30
• First posted: 2024-01-10
• Last updated: 2026-02-17

Locations

2 sites across 2 countries: Chile, India