ColoSeal™ ICD System Anastomotic Protection Pivotal Study

StatusActive, Not Recruiting
PhaseNot applicable
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

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Trial flagged as At Risk
Primary completion moved at least 9 months later Feb 2028 → Dec 2028
See other at-risk trials from Averto Medical, Inc.

Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fields
  2. Enrollment closed, study ongoing
    • Eligibility criteria expanded, about 19 words
    • Site details revised at 9 of 9 sites
  3. Primary and study completion pushed from Feb 2028 to Dec 2028
    • Recruitment opened
    • Trial sites expanded: 2 → 9 locations
    • Start date changed from estimate of Apr 2026 to Jun 19, 2026
    v2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this clinical investigation is to evaluate the safety of the ColoSeal ICD System by evaluating its effectiveness in reducing the stoma creation rate and by comparing the rate of major complications to current standard of care for rectal cancer surgery with a diverting ostomy.
Trial Details
NCT Number NCT07429110
Lead Sponsor Averto Medical, Inc.
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Rectal Cancer Surgery
Related terms Rectal Neoplasms
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov