NCT06454916

Functional Lumen Opening With Self-Forming Magnetic Anastomosis

GI Windows Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating Small Bowel Anastomoses in Patients Undergoing Surgical Procedures

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: GI Windows, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this trial is to investigate the safety and effectiveness of the Flexagon SFM system plus OTOLoc when used to create a small bowel anastomosis in subjects undergoing laparoscopic small bowel surgery.

Detailed description

This is a multicenter, pivotal study in which clinical outcomes will be prospectively evaluated for a minimum of 70 subjects undergoing anastomosis creation using the Flexagon SFM system plus OTOLoc.

Conditions

• Small Bowel Anastomosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-10-04
• Primary completion: 2025-06-30
• Completion: 2025-10-01
• First posted: 2024-06-12
• Last updated: 2025-11-13

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study