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
Not Yet Recruiting

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Conditions

  • Hydrocephalus

Eligibility Criteria

Sex
ALL
Age
5 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • wireless thermal anisotropy measurement device — DEVICE
    Wireless wearable thermal anisotropy measurement device designed for use at home

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

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

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

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 (1)

FacilityCityStateZIPSite coordinators
Rhaeos Inc.ChicagoIllinois60642
Anna Somera
[email protected]
8558143569

Find similar trials in Chicago, IL

By research site
Rhaeos Inc.· Chicago, IL

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