Using Flexagon Plus OTOLoc for Colon Surgery
GI Windows Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating Ileo-colic and Colo-colonic Anastomoses in Patients Undergoing Surgical Procedures
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 65 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | GI Windows, Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy, prednisone |
| Locations | 2 sites (Santiago, Huechuraba, Región Metropolitana and 1 other locations) |
| Trial ID | NCT06915818 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with uncontrolled diabetes, severe obesity, or specific gastrointestinal anomalies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve surgical outcomes and reduce complications associated with colon anastomosis.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating that this may be a novel method in the field.
Eligibility criteria
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 this trial is running
Santiago, Huechuraba, Región Metropolitana and 1 other locations
- Clinica Colonial Hospital — Santiago, Huechuraba, Región Metropolitana, Chile (Not_yet_recruiting)
- Mohak Hitech Specialty Hospital — Indore, Madhya Pradesh, India (Recruiting)
Study contacts
- Principal investigator: Mohit Bhandari, MD — Mohak Hitech Specialty Hospital
- Study coordinator: Peter Lukin
- Email: peter.lukin@giwindows.com
- Phone: +1 7814717901
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.