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

NCT07695558 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: GIW 25-001
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Small Bowel Anastomosis

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Successful Anastomosis Creation without the Need for Reoperation

  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

Study Arms (2)

Duodeno-ileal diversion anastomosis

OTHER

Small Bowel Anastomosis with Flexagon SFM Device

Device: Small Bowel Anastomosis

Jejunum-jejunum & ileal-ileal anastomosos

OTHER

Small Bowel Anastomosis with Flexagon SFM Device with OTOLoc

Device: Small Bowel Anastomosis

Interventions

Small Bowel Anastomosis DEVICE

Small Bowel Anastomosis

Also known as: Flexagon & Flexagon Plus OTOLoc systems

Duodeno-ileal diversion anastomosis; Jejunum-jejunum & ileal-ileal anastomosos

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>21 years of age, at the time of informed consent
• 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
• Willing and able to comply with the Registry procedures and provide written informed consent to participate in the post market study

You may not qualify if:

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

Sponsors & Collaborators

• GI Windows, Inc.: lead

Central Study Contacts

Pete Lukin

CONTACT

978 761 0183; peter.lukin@giwindows.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 10, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share