Clinical Trial

Initial Safety of SFM Plus OTOLoc for Creating Side-to-side or End-to-side Colorectal Anastomoses

Study acronym: Colonic
Recruiting
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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.
Protocol Amendment History 3 changes
notable Enrollment increased: 20 -> 30 participants 2026-07-07
notable Primary completion pushed: 2026-06 -> 2026-10 2026-07-07
minor Completion pushed: 2026-08 -> 2026-12 2026-07-07
Trial Details
NCT Number NCT07276529
Lead Sponsor GI Windows, Inc.
Conditions Colorectal Cancer, Diverticular Diseases
Enrollment 30 participants
Start Date 2026-04-01
Primary Completion 2026-10 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-06