RecruitingNot Applicable

Flexagon Plus OTOLoc Colon Anastomosis in Patients Undergoing Surgery

Chile, India65 participantsStarted 2025-03-29

Plain-language summary

The primary objective of this trial is to investigate the safety and effectiveness of the Flexagon SFM system plus OTOLoc when used to create a Ileo-colic and Colo-colonic anastomoses in participants undergoing colon surgery.

Who can participate

Age range22 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Aged 22 years or older at screening
✓. Candidate for surgery requiring Right Hemicolectomy or Sigmoid / Low Anterior resection (with anastomosis above the peritoneal reflection) with cardiac/medical clearance for surgery
✓. Able to understand and sign informed consent document
✓. American Society of Anesthesiologists (ASA) score \< IV at time of procedure
✓. All cancer patients must have completed chemotherapy ≥2 months prior to procedure
✓. Lives, and intends to remain, within a 300 kilometers radius of study center for the duration of the study
✓. Able to refrain from smoking during study follow-up period

Exclusion criteria

✕. Known or suspected allergy to silicone, nickel, titanium or Nitinol
✕. BMI \> 55 kg/m2
✕. Uncontrolled diabetes (defined as HbA1c \>10%)
✕. Congenital or acquired anomalies of the GI tract, including atresia or malrotation that would inhibit passing of SFM magnet
✕. Diagnosed with obstructed or perforated colon cancer
✕. 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
✕. Any previous major surgery on the stomach, duodenum, hepatobiliary tree, pancreas, Whipple or right colon
✕. History of recurrent small bowel obstructions.

What they're measuring

Number of Participants with Successful Anastomosis Creation without the Need for Reoperation

Timeframe: 30 Days

Trial details

NCT IDNCT06915818

SponsorGI Windows, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05

Contact for this trial

Peter Lukin

+1 7814717901 peter.lukin@giwindows.com

View on ClinicalTrials.gov More Colon Anastomosis trials