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

Part of paid clinical trials in San Francisco, California.

Sponsor
Rhaeos, Inc.
Study ID
NCT06410885
Status
Not Yet Recruiting

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Conditions

  • Hydrocephalus

Eligibility Criteria

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

Interventions

  • Thermal Anisotropy Measurement Device — DEVICE
    The study device is a non-invasive sensor that is placed on the study subject's skin overlying an existing implanted CSF shunt. It uses an integrated thermal actuator and temperature sensors to assess shunt flow.

Study Details

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).

Key Dates

Start date
Jun 30, 2025
Status verified
May 2025
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Observational, part 1 (blinded)
  • Experimental: Diagnostic, part 2 (unblinded)

Primary Outcome Measure

Study device negative predictive value (NPV) [ Time Frame: Up to 7 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCSF Benioff Children's HospitalSan FranciscoCalifornia94158
Catalina Pen
[email protected]
415-353-2342

Find similar trials in San Francisco, CA

By research site
UCSF Benioff Children's Hospital· San Francisco, CA

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