NCT05064722

Duodenal-Ileal Diversion in Obese Patients Undergoing Primary Sleeve or Those With Inadequate Weight Loss After Sleeve

Initial Safety and Device Functionality of the Self-Forming Magnetic Anastomosis Device to Create a Duodenal-Ileal Diversion in Obese Patients Undergoing Primary Sleeve (SNAP-S) or Those With Inadequate Weight Loss After Sleeve (SNAP-PS)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: GI Windows, Inc. · Industry
• Sex: All
• Age: 22 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 dual-path duodenal-ileal (D-I) diversion 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). Additionally, the study is designed to evaluate the potential of the SNAP-S/SNAP-PS procedures to induce weight loss and to improve metabolic comorbidities in obese subjects.

Detailed description

This is a single-arm, single-center, early feasibility study to evaluate the use of the SFM Anastomosis System for creation of a D-I diversion 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. Five patients will be enrolled in each cohort. Adult male and female subjects between the ages of 22 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 dual-path enteral diversion using the SFM anastomosis device in which the duodenum will be connected to the ileum with the creation of a side-by-side anastomosis using the SFM device and delivery systems. For subjects undergoing concurrent sleeve gastrectomy and D-I Diversion (SNAP-S cohort) it is anticipated that the D-I diversion will be created first followed by the sleeve gastrectomy (unless the investigator determines that the reverse order is more appropriate for a particular subject).

Conditions

• Obesity, Morbid

Interventions

Type	Name	Description
DEVICE	Self Forming Magnets (SFM)	To create the duodenal-ileal diversion, the duodenal magnet will be placed transorally in the proximal duodenum and the distal magnet will be placed in the ileum. Magnets are coupled and a compression induced anastomosis is created.

Timeline

• Start date: 2021-11-08
• Primary completion: 2024-04-15
• Completion: 2024-10-09
• First posted: 2021-10-01
• Last updated: 2024-10-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study