Post Market Study of the Flexagon Only System and Flexagon Plus OTOLoc for Creation of Side-to-Side Duodeno-Ileal Diversion & Flexagon Plus OTOLoc Self Forming Magnet (SFM) System for Creation of Side-to-Side Jejunum-Jejunum and Ileal-Ileal Anastomoses

July 8, 2026 updated by: GI Windows, Inc.
The objective of this study is to confirm the safety and effectiveness of the Flexagon & Flexagon Plus OTOLoc systems when used to create respective side-to-side anastomosis in participants undergoing laparoscopic / endoscopic small bowel surgery.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, multicenter, single-arm post market study of 70 minimum treated patients.

Eligible patients requiring side-to-side duodeno-ileal, jejunum-jejunum & ileal-ileal anastomosis will be evaluated for participation in the study.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. >21 years of age, at the time of informed consent
  2. Indicated for a side-to-side duodeno-ileal diversion, jejunum-jejunum or ileal-ileal anastomosis and no other concomitant surgical procedures (i.e. hiatal hernia repair, ventral hernia repair or gallbladder removal) planned in conjunction with SFM device placement
  3. Willing and able to comply with the Registry procedures and provide written informed consent to participate in the post market study

Exclusion Criteria:

  1. Participant does not provide informed consent to be enrolled and followed in the study
  2. Participants for whom medical condition warrants use of device outside of indication for use
  3. Breast-feeding, pregnant, or planning on becoming pregnant during the follow-up period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Duodeno-ileal diversion anastomosis
Small Bowel Anastomosis with Flexagon SFM Device
Device: Small Bowel Anastomosis
Small Bowel Anastomosis
Other Names:
  • Flexagon & Flexagon Plus OTOLoc systems
Other: Jejunum-jejunum & ileal-ileal anastomosos
Small Bowel Anastomosis with Flexagon SFM Device with OTOLoc
Device: Small Bowel Anastomosis
Small Bowel Anastomosis
Other Names:
  • Flexagon & Flexagon Plus OTOLoc systems

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Successful Anastomosis Creation without the Need for Reoperation
Time Frame: 30 Days
The study's primary endpoint (patient success) is defined as successful anastomosis created with the Flexagon SFM without placement procedure, device or target anastomosis-related reoperation through 30 days.
30 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GI Windows, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

July 2, 2026

First Submitted That Met QC Criteria

July 8, 2026

First Posted (Actual)

July 10, 2026

Study Record Updates

Last Update Posted (Actual)

July 10, 2026

Last Update Submitted That Met QC Criteria

July 8, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • GIW 25-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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