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NCT06409286

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

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
Observational
Intervention type
device
Sponsor & location
Primary sponsor
Rhaeos, Inc.
Timeline & enrollment
Phase
N/A
Start date
May 01, 2024
End date
Dec 01, 2024
Enrollment
17 participants
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
HydrocephalusHydrocephalus, unspecifiedOther hydrocephalusCongenital hydrocephalusObstructive hydrocephalus
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06409286
Type
Device Trial
About this record

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.

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.