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FOCUSNCT06915818

Flexagon Plus OTOLoc Colon Anastomosis in Patients Undergoing Surgery

StatusActive, Not Recruiting
PhaseNot applicable
Primary completion (estimated)

At risk: Primary completion moved at least 5 months later.

See at-risk trials from GI Windows, Inc.

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Record History

All 5 versions: 5 with changes below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 27 words Show 4 more changesShow less
    • Enrollment closed, study ongoing
    • Primary completion pushed from Aug 2026 to Feb 2027
    • Study completion pushed from Nov 2026 to Apr 2027
    • Site details revised at 2 of 2 sites
  2. Primary completion pushed from May 2026 to Aug 2026
    • Study completion pushed from Jul 2026 to Nov 2026
    v4
  3. Primary completion date: Dec 2025 to May 2026
    • Study completion date: Mar 2026 to Jul 2026
    v3
  4. Enrollment target: 56 to 65
    • Study sites: 1 to 2
    v2
  5. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Number of Participants with Successful Anastomosis Creation without the Need for Reoperation
Timeframe: 30 Days

Arms and interventions

Study Group: Prospective Evaluation of Flexagon SFM Device with OTOLocExperimental

This is a multicenter, single-arm study in which clinical outcomes are prospectively evaluated for subjects undergoing ileo-colic and colo-colonic anastomosis using the Flexagon SFM Device with OTOLoc.

Devices: Ileo-colic and colo-colonic Anastomosis with Flexagon SFM and OTOLoc

Sites

2 sites in 2 countries

Chile 1, India 1