Flow Detection in Open and Closed Shunt Valve Periods

Part of paid clinical trials in Peoria, Illinois.

Sponsor
Rhaeos, Inc.
Study ID
NCT07478926
Status
Recruiting
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Conditions

  • Hydrocephalus

Eligibility Criteria

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

Interventions

  • Rhaeos Shunt Monitoring System — DEVICE
    characters, and fully aligned with your protocol: The intervention consists of use of a noninvasive, wireless thermal flow detection device to assess cerebrospinal fluid (CSF) flow in an existing implanted shunt. The device is externally applied to intact skin over the shunt tubing, typically near the clavicle, and delivers controlled, imperceptible thermal energy while measuring resulting temperature gradients associated with CSF flow. Measurements are performed using a sponsor-provided tablet application that encodes results to maintain blinding. In some participants with programmable shunt valves, measurements are obtained under both prescribed flow-permissive settings and a temporary manufacturer-reported "virtual off" valve setting, after which the valve is returned to the prescribed setting. Device data are collected for research purposes only and are not used to guide clinical care.

Study Details

This study is evaluating a new, noninvasive device designed to detect whether cerebrospinal fluid (CSF) is flowing through a surgically implanted shunt. CSF shunts are commonly used to treat hydrocephalus, but it can be difficult to tell whether a shunt is working properly without invasive testing or imaging that does not directly measure flow. The study device is a small, wireless sensor placed on the skin over the shunt tubing, typically near the collarbone. It uses gentle, controlled warmth to measure temperature changes that indicate whether fluid is flowing inside the shunt. The device does not break the skin and does not change a participant's medical care. This study will enroll children and adults who already have a CSF shunt and who do not have new or worsening symptoms of shunt malfunction. All participants will have a measurement taken while their shunt valve is at its usual prescribed setting. Some participants with programmable shunt valves will also have a second measurement taken after their valve is temporarily adjusted to a setting intended to stop or greatly reduce flow ("virtual off"). After this measurement, the valve will be returned to its prescribed setting. The study device results will not be shown to participants or their medical providers and will not be used to make treatment decisions. The goal of the study is to determine how well the device can distinguish between shunts that are allowing flow and those that are not. Participants will be monitored for a short period after device use and, if applicable, after any valve adjustment. The main risks of participation are mild skin irritation from the adhesive or temporary symptoms related to valve adjustment. Participants are not expected to receive a direct medical benefit, but the information gained may help improve future diagnosis of shunt function.

Key Dates

Start date
Jan 27, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
55 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Other: CSF Shunt Flow Assessment with Wireless Thermal Device
    Participants undergo noninvasive assessment of cerebrospinal fluid (CSF) shunt flow using a wireless thermal flow detection device placed on the skin overlying the shunt tubing. All participants have a measurement performed at their prescribed shunt valve setting. Participants with programmable valves capable of a manufacturer-reported "virtual off" setting may undergo an additional measurement after temporary valve adjustment to reduce or stop CSF flow, followed by return of the valve to the prescribed setting. Device results are encoded and blinded to participants and clinical staff and are not used for clinical decision-making. Participants are monitored for adverse events during and after device use.

Primary Outcome Measure

Sensitivity and Specificity [ Time Frame: Day 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
OSF HealthcarePeoriaIllinois61602
Anna Somera
[email protected]
855-814-3569
Richard Webb, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Peoria, IL

By research site
OSF Healthcare· Peoria, IL

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