Magnets may replace stitches in colon surgery
NCT ID NCT06915818
First seen Jun 24, 2026 · Last updated Jul 07, 2026 · Updated 3 times
Summary
This study tests a new magnetic device (Flexagon SFM) to connect parts of the colon after surgery, instead of traditional stitches or staples. About 65 adults undergoing colon surgery will receive the device via laparoscopy or endoscopy. The goal is to see if the magnetic connection is safe and effective, reducing the need for repeat surgeries.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Flexagon Self-Forming Magnet and OTOLoc device
- What this could lead to
- If successful, this magnetic device could offer a safer, less invasive way to reconnect the colon after surgery, reducing the need for repeat operations.
- What could go wrong
- This is an early feasibility study with only 65 participants, so results may not apply to everyone. The device could fail to create a proper connection or cause 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 65 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Nov 2026
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. Aged 22 years or older at screening 2. Candidate for surgery requiring Right Hemicolectomy or Sigmoid / Low Anterior resection (with anastomosis above the peritoneal reflection) with cardiac/medical clearance for surgery 3. Able to understand and sign informed consent document 4. American Society of Anesthesiologists (ASA) score \< IV at time of procedure 5. All cancer patients must have completed chemotherapy ≥2 months prior to procedure 6. Lives, and intends to remain, within a 300 kilometers radius of study center for the duration of the study 7. Able to refrain from smoking during study follow-up period Exclusion Criteria: 1. Known or suspected allergy to silicone, nickel, titanium or Nitinol 2. BMI \> 55 kg/m2 3. Uncontrolled diabetes (defined as HbA1c \>10%) 4. Congenital or acquired anomalies of the GI tract, including atresia or malrotation that would inhibit passing of SFM magnet 5. Diagnosed with obstructed or perforated colon cancer 6. Any documented conditions for which endoscopy and/or laparoscopy would be contraindicated or history of previous technically difficult or failed endoscopy that may suggest difficulty during endoscopic delivery of magnets 7. Any previous major surgery on the stomach, duodenum, hepatobiliary tree, pancreas, Whipple or right colon 8. History of recurrent small bowel obstructions. 9. Coagulation deficiency not normalized by medical treatment or platelet count \<50,000/µL 10. Known moderate to severe renal disease (eGFR \< 44 milliliters per minute per 1.73m2) or ongoing dialysis 11. Hyperkalemia / hypercoagulability or prior Venus Thromboembolism / Pulmonary Embolism 12. Immunocompromised (e.g., active treatment for malignancies, hematologic malignancy, on immunosuppressive therapy, moderate or severe primary immunodeficiency, advanced or untreated HIV, active treatment with high-dose corticosteroids (i.e., 20 or more mg of prednisone or equivalent per day when administered for 2 or more weeks prior to surgery) or other immunosuppressive or immunomodulatory agents 13. Congestive heart failure with ejection fraction \<35% or clinically significant arrhythmia (any rhythm disturbances except sinus tachycardia, sinus bradycardia or a sinus rhythm with premature atrial or ventricular complexes) 14. Decompensated chronic obstructive lung disease 15. Active or suspected infection at the surgical site or a CDC Class 3/contaminated or Class 4/dirty-infected surgical wound. 16. Contraindication to general anesthesia 17. Breast-feeding, pregnant, or planning on becoming pregnant during the follow-up period 18. Currently participating or has participated in another clinical trial within the past 30 days and is receiving/has received an investigational drug, device, or biologic agent 19. Contraindication to general anesthesia 20. Participant is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites in 2 countries. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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Clinica Colonial Hospital
NOT_YET_RECRUITINGSantiago, Huechuraba, Región Metropolitana, 8580000, Chile
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Mohak Hitech Specialty Hospital
RECRUITINGIndore, Madhya Pradesh, 454555, India
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