Initial Safety of SFM Plus OTOLoc for Creating Side-to-side or End-to-side Colorectal Anastomoses (NCT07276529) | Clinical Trial Compass
RecruitingNot Applicable
Initial Safety of SFM Plus OTOLoc for Creating Side-to-side or End-to-side Colorectal Anastomoses
United States20 participantsStarted 2026-04-01
Plain-language summary
The primary objective of this trial is to investigate the safety and effectiveness of the Flexagon 25mm SFM system plus OTOLoc when used to create a side-to-side Ileo-colic, Colo-colonic and side-to-side or end-to-side colorectal anastomoses in participants undergoing colon surgery. This will be evaluated via a composite safety/effectiveness endpoint of patient success defined as successful creation of the target anastomosis without placement procedure, device or target anastomosis related reoperation through 30 days.
Who can participate
Age range22 Years
SexALL
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Inclusion criteria
✓. Aged 22 years or older at screening
✓. Candidate for surgery requiring Right of Left Hemicolectomy or Sigmoidectomy or Low Anterior resection 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 150-mile 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
✕. Participants with an acute diagnosis of obstructed or perforated colon cancer at the time of the Screening Visit
✕. Any documented conditions for which endoscopy and/or laparoscopy would be contraindicated or history of previous failed endoscopy that may suggest difficulty during endoscopic delivery of magnets
What they're measuring
1
Successful anastomosis created with the Flexagon SFM plus OTOLoc without reoperation.