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Pilot Study of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Primary completion date changed from estimate of Jul 2025 to Apr 23, 2025
    • Study completion date: Apr 2027 to Apr 2030
    v10
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v9
  3. Primary completion date: Dec 2024 to Jul 2025v8
  4. Primary completion date: Dec 2023 to Dec 2024v7
  5. Primary completion date: Feb 2023 to Dec 2023v6
Show 4 earlier versionsHide 4 earlier versions
  1. Primary completion date: Aug 2022 to Feb 2023v5
  2. Eligibility criteria shortened, about 7 wordsv4
  3. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Jul 2022 to Aug 2022
    • Start date changed from estimate of Mar 2022 to Mar 10, 2022
    • Site details revised
    • Study title expanded, about 3 words
  4. Secondary endpoints: details revised at 3 of 10 entriesv2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The eShunt System includes proprietary delivery componentry and the eShunt Implant, a permanent implant deployed in a minimally invasive, neurointerventional procedure. The eShunt Implant is designed to mimic the function of the arachnoid granulations by draining excess cerebrospinal fluid (CSF) from the intracranial subarachnoid space (SAS) into the venous system.
Trial Details
NCT Number NCT05250505
Lead Sponsor CereVasc Inc
Collaborators: AlvaMed, Inc., Simplified Clinical Data Systems, LLC, Bioscience Consulting, Inc.
Conditions
(from sponsor)		 Hydrocephalus, Normal Pressure, Hydrocephalus
Related terms Hydrocephalus, Hydrocephalus, Normal Pressure
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov