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Assessment of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device in Asymptomatic Patients

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 15, 2025 (before its estimated May 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Study sites: 0 to 1
    • Start date: May 2025 to Jun 2025
    v4
  2. Primary and study completion dates: Mar 2025 to May 2026
    • Start date: Nov 2024 to May 2025
    v3
  3. Start date: Jun 2024 to Nov 2024
    • Primary and study completion dates: Dec 2024 to Mar 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 the study device, FlowSense®, a sensor for non-invasively assessing cerebrospinal fluid (CSF) shunt flow. Subjects with an existing implanted ventricular CSF shunt will be evaluated with the study device in an outpatient setting to determine the negative predictive value (NPV; Part 1, blinded) and explore changes in surveillance imaging, health resource utilization, and visit duration during routine follow-up visits (Part 2, unblinded).
Trial Details
NCT Number NCT06410885
Lead Sponsor Rhaeos, Inc.
Conditions
(from sponsor)		 Hydrocephalus
Related terms Hydrocephalus
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov