Magnet magic: new device connects bowel without stitches
NCT ID NCT06454916
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new magnetic device (Flexagon SFM plus OTOLoc) to connect two parts of the small bowel during keyhole surgery. 79 adults who needed this type of surgery took part. The main goal was to see if the device could create a successful connection without needing another operation within 30 days.
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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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79 people
The number who actually took part.
- Started
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Oct 2024
- Finished
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Oct 2025
- 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 laparoscopic small bowel surgery requiring small bowel anastomosis 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. Lives, and intends to remain, within a 185-mile radius of study center for the duration of the study 6. 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 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 7. Any previous major surgery on the stomach, duodenum, hepatobiliary tree (excluding laparoscopically removed gallbladder or prior sleeve gastrectomy), pancreas or right colon 8. Coagulation deficiency not normalized by medical treatment or platelet count \<50,000/µL 9. Known moderate to severe renal disease (eGFR \< 44 milliliters per minute per 1.73m2) or ongoing dialysis 10. Hyperkalemia / hypercoagulability or prior Venus Thromboembolism / Pulmonary Embolism 11. 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 12. Active H. pylori infection 13. Active or suspected infection at the surgical site or a CDC Class 3/contaminated or Class 4/dirty-infected surgical wound. 14. Obstructive Sleep Apnea on CPAP unless assessed and cleared by independent physician 15. Contraindication to general anesthesia 16. Breast-feeding, pregnant, or planning on becoming pregnant during the follow-up period 17. 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 18. Subject is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Duke Regional Hospital
Durham, North Carolina, 27704, United States
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Endeavor Health
Evanston, Illinois, 60201, United States
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Fresno Community Hospital and Medical Center
Clovis, California, 93611, United States
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Orlando Health
Orlando, Florida, 32806, United States
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Seger Bariatrics and Metabolism, LLC
San Antonio, Texas, 78229, United States
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UT Health Houston
Houston, Texas, 77401, United States
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University of Miami
Coral Gables, Florida, 33146, United States
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