Flexagon Plus OTOLoc Colon Anastomosis in Patients Undergoing Surgery

Launched by GI WINDOWS, INC. · Apr 2, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new method for performing colon surgery using a system called Flexagon SFM combined with OTOLoc. The goal is to see how safe and effective this method is for creating connections between different parts of the colon, which is an important step in surgeries like Right Hemicolectomy or Sigmoid/Low Anterior resection. The study is currently recruiting participants aged 22 and older who are cleared for surgery and live within 300 kilometers of the study center.

To be eligible for this trial, participants must not have certain health conditions, such as severe diabetes or a history of major surgeries on the stomach or colon that could complicate the procedure. Those who join the trial can expect to undergo regular follow-ups and will need to refrain from smoking during this time. If you or a family member are considering this study, it's a chance to help advance medical knowledge while also receiving care for a serious condition.

Gender

ALL

Eligibility 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