Status: Recruiting
Initial Safety of SFM Plus OTOLoc for Creating Side-to-side or End-to-side Colorectal Anastomoses
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.
Participants needed: 20
Trial details
Age: 22+Biological sex: AllType: InterventionalSponsor: GI Windows, Inc.Updated: Apr 13, 2026Locations: 1
Eligibility criteria
Aged 22 years or older at screening [+6]
Known or suspected allergy to silicone, nickel, titanium or Nitinol [+18]