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

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Rhaeos, Inc.
Study ID
NCT06409286
Status
Not Yet Recruiting

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Conditions

  • Hydrocephalus

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Thermal Anisotropy Measurement Device — DEVICE
    A wireless device for non-invasively assessing CSF shunt flow

Study Details

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.

Key Dates

Start date
Jul 31, 2025
Status verified
May 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
17 participants (estimated)

Arms

  • Arm: Shunted patients undergoing surgery
    Patients with an existing implanted ventriculoperitoneal shunt who are experiencing shunt malfunction symptoms and require shunt revision surgery per standard of care shunt evaluation

Primary Outcome Measure

Flowsense Sensitivity [ Time Frame: Upto 7 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University in St. LouisSt LouisMissouri63110
Diego Morales
[email protected]
314-454-6120

Find similar trials in St Louis, MO

By research site
Washington University in St. Louis· St Louis, MO

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