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Functional Lumen Opening With Self-Forming Magnetic Anastomosis

NCT06454916 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2025-11-13

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • GI Windows, Inc.

    lead INDUSTRY

Principal Investigators

  • Erik Wilson, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-04
Primary Completion
2025-06-30
Completion
2025-10-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06454916 on ClinicalTrials.gov