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

NCT06409286 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 17

Last updated 2025-05-15

No results posted yet for this study

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.

Conditions

  • Hydrocephalus

Interventions

DEVICE

Thermal Anisotropy Measurement Device

A wireless device for non-invasively assessing CSF shunt flow

Sponsors & Collaborators

  • Rhaeos, Inc.

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06409286 on ClinicalTrials.gov