ColoSeal™ ICD System Safety and Feasibility Studies

Study acronym: PROTECT I
StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 3 months later across 2 updates Sep 30, 2026 → Dec 31, 2026
See other at-risk trials from Averto Medical, Inc.

Record History

See every version on ClinicalTrials.gov ↗

  1. Enrollment reopened Show 5 more changesShow less
    • Primary completion pushed from Oct 30, 2026 to Dec 31, 2026
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints: details revised at 2 of 6 entries
    • Study description revised
    • Site details revised at 3 of 3 sites
  2. Enrollment closed, study ongoingv4 Show 5 more changesShow less
    • Primary completion pushed from Sep 30, 2026 to Oct 30, 2026
    • Study completion pushed from Dec 31, 2026 to Mar 31, 2027
    • Site details revised at 3 of 3 sites
    • Study title revised
    • Study description expanded, about 3 words
  3. Enrollment target: 15 to 90v3 Show 5 more changesShow less
    • Primary completion date: Jun 30, 2026 to Sep 30, 2026
    • Study completion date: Aug 31, 2026 to Dec 31, 2026
    • Eligibility criteria expanded, about 69 words
    • Secondary endpoints: details revised at 2 of 6 entries
    • Study description expanded, about 14 words
  4. Primary completion date: Dec 31, 2024 to Jun 30, 2026
    • Study sites: 2 to 3
    • Study completion date: Mar 31, 2025 to Aug 31, 2026
    v2
  5. 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 studies aim to evaluate the safety and feasibility of the ColoSeal Intraluminal Colonic Diversion (ICD) System in two prospective, multicenter, single-arm studies. The ColoSeal ICD System is intended to be used to protect a damaged segment of colon such as a surgical anastomosis, anastomosis leak, or perforation from contact with fecal flow for up to 14 days. The device will be evaluated in adult patients with rectal and rectosigmoid cancer undergoing a resection with a colorectal anastomosis.
Trial Details
NCT Number NCT06402188
Lead Sponsor Averto Medical, Inc.
Conditions
(from sponsor)		 Colorectal Cancer
Related terms Colorectal Neoplasms
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov