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NCT Number: NCT07695558

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

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.

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Key information

Conditions

Small Bowel Anastomosis

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >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

Exclusion criteria

  • 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.

Treatment and study plan

Small Bowel Anastomosis

Device

Small Bowel Anastomosis

Other names: Flexagon & Flexagon Plus OTOLoc systems

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Pete Lukin

CONTACT

[email protected]

978 761 0183

Sponsors and collaborators

Lead sponsor

GI Windows, Inc.

Industry

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 10, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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