Assessment of CSF Shunt Flow During Activities of Daily Living and Sleep With a Thermal Measurement Device

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Rhaeos, Inc.
Study ID
NCT07050628
Status
Recruiting
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Conditions

  • Hydrocephalus

Eligibility Criteria

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

Interventions

  • wireless thermal anisotropy measurement device — DEVICE
    Wireless wearable thermal anisotropy measurement device designed for use at home will be provided to study subjects in both study arms

Study Details

This study evaluates the performance of a device for non-invasively assessing cerebrospinal fluid (CSF) shunt flow over multiple measurements performed by a study subject during activities of daily living and sleep

Key Dates

First listed
Jul 3, 2025
Start date
Nov 10, 2025
Status verified
Aug 2026
Primary completion
Aug 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
28 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: No Recent Revision
    Pediatric hydrocephalus patients with an existing ventricular CSF shunt and a history of stable ventricular size, no shunt revision in the previous 2 years, and no current symptoms of shunt failure will be enrolled.
  • Experimental: Recent Revision
    Pediatric hydrocephalus patients with an existing ventricular CSF shunt and a shunt revision in the previous 7 days who the investigator judges will likely be discharged within 4 days of the enrollment date will be enrolled.

Primary Outcome Measure

Adverse Device Effects [ Time Frame: 30 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Rhaeos Inc.ChicagoIllinois60642
Anna Somera
[email protected]
855-814-3569
Virginia Commonwealth University Medical CenterRichmondVirginia23298
Lisa Merck
[email protected]
804-628-8995

Find similar trials in Chicago, IL

By research site
Rhaeos Inc.· Chicago, ILVirginia Commonwealth University Medical Center· Richmond, VA

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