Magnetic surgery breakthrough? new device aims to simplify Stomach-Intestine connections
NCT ID NCT06915337
First seen Jun 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times
Summary
This study is testing a new device that uses magnets to create a connection between the stomach and the small intestine during surgery. The device is placed using minimally invasive tools like a laparoscope or endoscope. The goal is to see if it can safely and effectively create this connection without the need for a second surgery. The trial will enroll 75 adults who are already scheduled for gastric surgery.
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 (SFM) device and OTOLoc access device
- What this could lead to
- If successful, this could offer a less invasive way to create connections in the digestive tract during surgery, potentially reducing complications and recovery time.
- What could go wrong
- This is an early-stage study with only 75 participants, so results may not apply to everyone. The device could fail to create a proper connection or cause complications requiring additional surgery.
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 75 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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Dec 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 gastric surgery requiring gastro-jejunal or gastro-ileal 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 300 kilometers 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 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 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 Participants with active H. pylori may continue with the screening process if they are treated via medication 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. Participant 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.
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