Clinical Trial

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

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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.
Summary
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-05-07; most recent amendment 2025-05-12.
Trial Details
NCT Number NCT06409286
Lead Sponsor Rhaeos, Inc.
Conditions Hydrocephalus
Enrollment 17 participants
Start Date 2025-07
Primary Completion 2025-12 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2025-05-15