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

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date changed from estimate of Apr 30, 2025 to Jun 15, 2025
    • Study completion date: Apr 30, 2030 to Jun 30, 2030
    v20
  2. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Jan 30, 2025 to Apr 30, 2025
    • Study completion date: Jan 30, 2030 to Apr 30, 2030
    • Site details revised at 11 of 11 sites
    v19
  3. Site details revised at 2 of 11 sitesv18
  4. Enrollment target: 30 to 50v17 Show 4 more changesShow less
    • Primary completion date: Oct 30, 2024 to Jan 30, 2025
    • Study completion date: Oct 30, 2029 to Jan 30, 2030
    • Study description revised
    • Site details revised at 11 of 11 sites
  5. Re-verified, no change to tracked fieldsv16
Show 14 earlier versionsHide 14 earlier versions
  1. Study sites: 8 to 11v15
  2. Study sites: 5 to 8v14
  3. Study sites: 4 to 5v13
  4. Enrollment target: 10 to 30
    • Eligibility criteria revised
    • Study description revised
    v12
  5. Primary completion date: Dec 30, 2023 to Oct 30, 2024
    • Study sites: 3 to 4
    • Study completion date: May 1, 2027 to Oct 30, 2029
    v11
  6. Primary completion date: Mar 1, 2023 to Dec 30, 2023v10
  7. Study sites: 2 to 3v9
  8. Site contacts updated at 1 of 2 sitesv8
  9. Primary completion date: Aug 1, 2022 to Mar 1, 2023
    • Study sites: 1 to 2
    v7
  10. Eligibility criteria shortened, about 7 wordsv6
  11. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 1, 2022 to Apr 20, 2022
    • Site details revised
    v5
  12. Study sites: 0 to 1v4
  13. Start date: Mar 1, 2022 to Apr 1, 2022
    • Primary completion date: Jul 1, 2022 to Aug 1, 2022
    • Study title expanded, about 3 words
    v3
  14. Secondary endpoints: details revised at 7 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a minimally invasive method of treating communicating hydrocephalus. The eShunt System includes a proprietary eShunt Delivery System and the eShunt Implant, a permanent implant deployed in a minimally invasive, neuro-interventional procedure. The eShunt System is intended to shunt cerebrospinal fluid from the intracranial subarachnoid space to the venous system for the treatment of patients with normal pressure hydrocephalus, reducing disability due to symptoms including one or more of gait disturbance, cognitive dysfunction and urinary incontinence.
Trial Details
NCT Number NCT05232838
Lead Sponsor CereVasc Inc
Collaborators: AlvaMed, Inc., Simplified Clinical Data Systems, LLC
Conditions
(from sponsor)		 Hydrocephalus, Normal Pressure, Hydrocephalus
Related terms Hydrocephalus, Hydrocephalus, Normal Pressure
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov