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Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated May 15, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Mar 2025 to Dec 2025
    • Study completion date: Apr 2025 to Dec 2025
    v7
  2. Primary completion date: Aug 2024 to Mar 2025
    • Study completion date: Dec 2024 to Apr 2025
    v6
  3. Study sites: 3 to 4v5
  4. Enrollment target: 30 to 130
    • Study sites: 1 to 3
    • Study completion date: Aug 2024 to Dec 2024
    • Eligibility criteria shortened, about 33 words
    v4
  5. Primary and study completion dates: Mar 2024 to Aug 2024v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Nov 2023 to Nov 17, 2023
    v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 evaluates the performance of a device for non-invasively assessing cerebrospinal fluid (CSF) shunt flow. Patients with an existing implanted shunt will wear the device to acquire longitudinal data.
Trial Details
NCT Number NCT06086561
Lead Sponsor Rhaeos, Inc.
Conditions
(from sponsor)		 Hydrocephalus
Related terms Hydrocephalus
Enrollment 130 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov