Magnetic bowel connectors could make surgery safer
NCT ID NCT07695558
First seen Jul 10, 2026 · Last updated Aug 20, 2026 · Updated 2 times
Summary
This study tests two devices—Flexagon and Flexagon Plus OTOLoc—that use magnets to create connections between sections of the small bowel during laparoscopic surgery. The goal is to see if they are safe and effective for people who need this type of bowel surgery. Researchers will check if the connection is made successfully without needing another operation within 30 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Flexagon and Flexagon Plus OTOLoc systems (self-forming magnet devices)
- What this could lead to
- If successful, these devices could offer a safer, less invasive way to create bowel connections during surgery, potentially reducing complications and recovery time.
- What could go wrong
- This is a post-market study with a small group (70 people), so results may not apply to everyone. Risks include device failure, need for reoperation, or bowel complications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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22 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
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How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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