Using Flexagon Plus OTOLoc for Colon Surgery
Official title: GI Windows Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating Ileo-colic and Colo-colonic Anastomoses in Patients Undergoing Surgical Procedures
Run by GI Windows, Inc. · NCT06915818 · Data updated 2026-11-12
This study is testing a new tool called Flexagon Plus OTOLoc to see if it can make colon surgery safer and help patients recover better.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 22 Years and up |
| Sex | All |
| Enrollment | 65 (estimated) |
| Sponsor | GI Windows, Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy, prednisone |
| Locations | 2 sites (Santiago, Huechuraba, Región Metropolitana and 1 other locations) |
| Status | Recruiting |
| Started | March 29, 2025 |
| Main results expected | August 2026 |
| Study ends | November 2026 |
| Registry record updated | July 6, 2026 |
| Trial ID | NCT06915818 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 22 and older who are scheduled for right hemicolectomy or sigmoid/low anterior resection with medical clearance for surgery.
✕Probably not a fit
Patients with uncontrolled diabetes, severe obesity, or specific gastrointestinal anomalies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the safety and effectiveness of the Flexagon Self Forming Magnet system combined with OTOLoc for creating Ileo-colic and Colo-colonic anastomoses in patients undergoing colon surgery. It is a prospective, multi-center, single-arm study that will assess the outcomes of this innovative approach in a surgical setting. Participants will be monitored for their recovery and any complications arising from the procedure.
Why it matters
Potential benefit: If successful, this approach could improve surgical outcomes and reduce complications associated with colon anastomosis.
How similar studies have gone: While this approach is innovative, similar studies have not been widely reported, indicating that this may be a novel method in the field.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Mohak Hitech Specialty Hospital
Indore, Madhya Pradesh, India Recruiting -
Clinica Colonial Hospital
Santiago, Huechuraba, Región Metropolitana, Chile Not yet recruiting
Study contacts
- Principal investigator: Mohit Bhandari, MD — Mohak Hitech Specialty Hospital
- Study coordinator: Peter Lukin
- Email: peter.lukin@giwindows.com
- Phone: +1 7814717901
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Magnet-assisted device (Flexagon SFM plus OTOLoc) to join sections of the colon
This will try a magnet-based device (Flexagon 25mm SFM plus OTOLoc) to create side-to-side or end-to-side colorectal connections in adults having laparoscopic colon surgery for cancer or diverticular disease.
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Using magnets to connect parts of the stomach during surgery
This study is testing a new way to connect parts of the stomach during surgery using magnets to see if it works safely and effectively for patients.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.