Assessment of Flow in Cerebrospinal Fluid Shunts With a Second Generation Wireless Thermal Anisotropy Measurement Device - Trial NCT06409286
Access comprehensive clinical trial information for NCT06409286 through Pure Global AI's free database. This phase not specified trial is sponsored by Rhaeos, Inc. and is currently Not yet recruiting. The study focuses on Hydrocephalus. Target enrollment is 17 participants.
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Study Focus
Sponsor & Location
Rhaeos, Inc.
Timeline & Enrollment
N/A
May 01, 2024
Dec 01, 2024
Primary Outcome
Flowsense Sensitivity
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06409286
Device Trial