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NCT06410885

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

Rhaeos, Inc.·ClinicalTrials.gov·device·Device trialNot yet recruiting
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Study focus
Disease/Condition
Hydrocephalus
Drug/Device/Intervention
Thermal Anisotropy Measurement Device
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Rhaeos, Inc.
Timeline & enrollment
Phase
N/A
Start date
Jun 01, 2024
End date
Dec 01, 2024
Enrollment
60 participants
Primary outcome

Study device negative predictive value (NPV)

Summary

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).

ICD-10 classifications
HydrocephalusHydrocephalus, unspecifiedOther hydrocephalusCongenital hydrocephalusObstructive hydrocephalus
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06410885
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT06410885 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 60 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.