Flow Detection in Open and Closed Shunt Valve Periods

NCT07478926 | Recruiting FDA Device

• 1 other identifier: 2025-04
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hydrocephalus

Keywords

hydrocephalus; wearable; shunt; valve

Outcome Measures

Primary Outcomes (1)

• Sensitivity and Specificity

  Evaluation of sensitivity and specificity using the main study data

  Day 1

Study Arms (1)

CSF Shunt Flow Assessment with Wireless Thermal Device

OTHER

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.

Device: Rhaeos Shunt Monitoring System

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.

CSF Shunt Flow Assessment with Wireless Thermal Device

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• Existing ventricular CSF shunt with an available "virtual off" setting which can be programmed noninvasively
• Region of intact skin overlying an unambiguously identifiable palpable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device
• Signed informed consent by subject or a parent or legal guardian, health care agent, or surrogate decision maker (according to local statutes)
• Subject-reported or documented history of successful valve adjustment(s)
• Existing ventricular CSF shunt
• Region of intact skin overlying an unambiguously identifiable palpable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device
• Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
• Subjects with planned "virtual off" measurement:
• Existing ventricular CSF shunt with an available "virtual off" setting which can be programmed noninvasively
• Subjects with planned adjustment to the "virtual off" setting only:
• Subject-reported or documented history of successful valve adjustment(s)
• Presence of more than one distal shunt catheter in the study device measurement region
• Presence of an interfering open wound or edema in the study device measurement region
• Shunt is difficult to palpate, or the shunt depth at the device measurement location is deeper than 5 mm from the skin surface via ultrasound measurement
• Shunt valve is set to an opening pressure of \>= 300 mm H2O, or the shunt system is otherwise set to substantially prevent shunt flow (e.g. Certas Plus valve programmed to a setting of 8 or a ligated shunt)

Sponsors & Collaborators

• Rhaeos, Inc.: lead

Study Sites (1)

OSF Healthcare

Peoria, Illinois, 61602, United States

RECRUITING

MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Anna Somera

CONTACT

855-814-3569; info@rhaeos.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: March 18, 2026
• Study Start: January 27, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)