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AMNIOX CORD Study - Radical Prostatectomy With and Without Cryopreserved Umbilical Cord Allograft

StatusActive, Not Recruiting
PhasePhase 2/3
Started
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Record History

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  1. Minor Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v12
  2. Notable Primary and study completion dates: Oct 1, 2026 to Apr 1, 2027v11
  3. Notable Primary and study completion dates: Oct 1, 2025 to Oct 1, 2026v10
  4. Minor Re-verified, no change to tracked fieldsv9
  5. Notable Primary and study completion dates: Oct 1, 2024 to Oct 1, 2025v8
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  1. Minor Study sites: 2 to 1v7
  2. Notable Phase: Not applicable to Phase 2/3v6 Show 5 more changesShow less
    • Primary completion date: Apr 1, 2023 to Oct 1, 2024
    • Study completion date: Apr 1, 2024 to Oct 1, 2024
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: 6 to 29
    • Site details revised at 1 of 2 sites
  3. Minor Site details revised at 1 of 2 sitesv5
  4. Notable Primary completion date: Apr 1, 2022 to Apr 1, 2023
    • Study completion date: Apr 1, 2023 to Apr 1, 2024
    v4
  5. Minor Re-verified, no change to tracked fieldsv3
  6. Minor Study description shortened, about 7 wordsv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
This study aims at evaluating if placement of CLARIX® CORD 1K during robotic prostatectomy decreases the time to achieve complete erectile and urinary function after the surgery. As part of the study, the patient will be asked to answer various questions after the surgery regarding sexual and urinary function.
Trial Details
NCT Number NCT04263025
Lead Sponsor Hackensack Meridian Health
Conditions
(from sponsor)
Prostate Cancer
Related terms Prostatic Neoplasms
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov