Functional Lumen Opening With Self-Forming Magnetic Anastomosis

NAActive, not recruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

October 4, 2024

Primary Completion Date

June 30, 2025

Study Completion Date

August 31, 2025

Conditions
Small Bowel Anastomosis
Interventions
DEVICE

Small Bowel Anastomosis with Flexagon SFM Device with OTOLoc

This study will investigate one type of intervention: small bowel anastomosis creation in subjects undergoing laparoscopic small bowel surgery. Flexagon SFMs and OTOLoc devices will be delivered laparoscopically into two different sections of small bowel that are intended to be anastomosed. An OTOLoc device will be deployed into the small bowel wall in one section of the small bowel to provide access for the deployment of a Flexagon SFM into that section of bowel. The process is repeated at the second section of bowel. Once deployed, the Flexagon SFMs are approximated and positioned, after which the SFMs are couple together to form the anastomosis, with the OTOLoc devices allowing fluidic communication between the two sections of bowel until the anastomosis is fully formed.

Trial Locations (7)

27704

Duke Regional Hospital, Durham

32806

Orlando Health, Orlando

33146

University of Miami, Coral Gables

60201

Endeavor Health, Evanston

77401

UT Health Houston, Houston

78229

Seger Bariatrics and Metabolism, LLC, San Antonio

93611

Fresno Community Hospital and Medical Center, Clovis

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GI Windows, Inc.

INDUSTRY

NCT06454916 - Functional Lumen Opening With Self-Forming Magnetic Anastomosis | Biotech Hunter | Biotech Hunter