Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device

Part of paid clinical trials in Tampa, Florida.

Sponsor
Rhaeos, Inc.
Study ID
NCT06086561
Status
Recruiting
Apply to this trial

Conditions

  • Hydrocephalus

Eligibility Criteria

Sex
ALL
Age
5 Years - 80 Years
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 a device for non-invasively assessing cerebrospinal fluid (CSF) shunt flow. Patients with an existing implanted shunt will wear the device to acquire longitudinal data.

Key Dates

Start date
Nov 17, 2023
Status verified
May 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
130 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Feasibility Assessment Cohort
    Non-invasive device data acquisition; study is not interventional

Primary Outcome Measure

Skin Temperature [ Time Frame: up to 90 days ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Tampa Marriott Water StreetTampaFlorida33602
Ann & Robert H. Lurie Children's Hospital of ChicagoChicagoIllinois60611-
MATTERChicagoIllinois60611
Northwest Special Recreation AssociationRolling MeadowsIllinois60008

Find similar trials in Tampa, FL

By research site
Tampa Marriott Water Street· Tampa, FLAnn & Robert H. Lurie Children's Hospital of Chicago· Chicago, ILMATTER· Chicago, ILNorthwest Special Recreation Association· Rolling Meadows, IL

Related Studies