ColonicNCT07276529
Initial Safety of SFM Plus OTOLoc for Creating Side-to-side or End-to-side Colorectal Anastomoses
At risk: Primary completion moved at least 7 months later.
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Record History
All 5 versions: 5 with changes below. See every version on ClinicalTrials.gov ↗
- Notable Primary completion pushed from Oct 2026 to Jun 2027
- Eligibility criteria expanded, about 26 words
- Study completion pushed from Dec 2026 to Jul 2027
- Study description expanded, about 2 words
Notable Enrollment increased: 20 → 30 participantsv4 Show 4 more changesShow less
- Eligibility criteria revised
- Primary completion pushed from Jun 2026 to Oct 2026
- Study completion pushed from Aug 2026 to Dec 2026
- Study sites: 1 to 2
- Minor Start date changed from estimate of Feb 2026 to Apr 1, 2026v3
- Notable Trial status: Not Yet Recruiting to Recruiting
- Start date: Jan 2026 to Feb 2026
- Site details revised
- Study First Submitted
- Notable: the plan changed
- Minor: routine updates
Endpoints
Primary
Successful anastomosis created with the Flexagon SFM plus OTOLoc without reoperation.
Timeframe: 30 days
Anastomosis success
Timeframe: 30 days
Secondary (3)
No Bleeding at anastomosis
No Leaks at anastomosis
No Obstructions at the anastomosis
Arms and interventions
Flexagon SFM plus OTOLoc for Magnet Colon AnastomosisExperimental
Patients will receive the Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating side-to-side Ileo-colic, Colo-colonic and side-to-side or end-to-side Colorectal Anastomoses in Patients Undergoing Surgical Procedures via endoscopic or laparoscopic delivery methods
Devices: Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating side-to-side Colon Anatomoses
Sites
2 sites in 1 country