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Assessment of Flow in Cerebrospinal Fluid Shunts With a Second Generation Wireless Thermal Anisotropy Measurement Device

StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
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

  1. Start date: Feb 2025 to Jul 2025
    • Study sites: 0 to 1
    • Primary and study completion dates: Sep 2025 to Dec 2025
    v4
  2. Start date: Nov 2024 to Feb 2025
    • Primary and study completion dates: Jun 2025 to Sep 2025
    v3
  3. Start date: May 2024 to Nov 2024
    • Primary and study completion dates: Dec 2024 to Jun 2025
    v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 thermal anisotropy measurement device for non-invasively assessing CSF shunt flow. Patients with an existing implanted shunt and symptoms of shunt malfunction who require shunt revision surgery will be evaluated with the study device to assess flow in CSF shunts as confirmed by surgical outcomes at 7 days. If successful, this study will show that the study device accurately distinguishes between functioning (flowing) and non-functioning (non-flowing) shunts.
Trial Details
NCT Number NCT06409286
Lead Sponsor Rhaeos, Inc.
Conditions
(from sponsor)		 Hydrocephalus
Related terms Hydrocephalus
Enrollment 17 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov