Recruiting

Flow Detection in Open and Closed Shunt Valve Periods

Rhaeos, Inc. · NCT07478926

Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation: Not posted. Ask the study team before screening.
Who can join: Any age listed · All sexes
Healthy volunteers: Not accepted (a condition is required)
Study type: Interventional · Not applicable
Target enrollment: 55
US sites recruiting: 1
Study start: January 27, 2026
Record last updated: March 18, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Rhaeos Shunt Monitoring System

Conditions: Hydrocephalus

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

Inclusion and Exclusion Criteria for Roll-In Subjects Inclusion criteria

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)

Inclusion and Exclusion Criteria for Main Study Subjects

Inclusion criteria

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)

Exclusion Criteria

Exclusion criteria

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)
Investigator judges that the subject is likely to be shunt independent (e.g. does not require a functional shunt for management of hydrocephalus)
Subject has more than one intact and presumed functional distal catheter
Subject-reported or documented history of serious adverse skin reactions to silicone-based adhesives
Subject-reported new or worsening symptoms of a possible shunt malfunction in the prior 7 days
Use of the study device would interfere with standard patient care, or emergency surgery that cannot be delayed, or participation in the study will interfere with, or be detrimental to, administration of optimal healthcare to the subject
Prior enrollment in this study
Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study

Exclusion Criteria for Main Study Subjects Exclusion criteria

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
Subject-reported or documented history of serious adverse skin reactions to silicone-based adhesives
Subject-reported new or worsening symptoms of a possible shunt malfunction in the prior 7 days
Use of the study device would interfere with standard patient care, or emergency surgery that cannot be delayed, or participation in the study will interfere with, or be detrimental to, administration of optimal healthcare to the subject
Prior enrollment in this study
Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study
Previous participation in a Rhaeos clinical study in which the study device (current generation) was used to acquire measurement data

Subjects with planned "valve normal" measurements:

Shunt system is set to substantially prevent shunt flow (e.g. ligated shunt)
Investigator judges that the subject is likely to be shunt independent (e.g. does not require a functional shunt for management of hydrocephalus)
Subject has more than one intact and presumed functional distal catheter

Recruiting US locations

OSF Healthcare
Peoria, IL 61602
Site contact: Anna Somera · 855-814-3569 · info@rhaeos.com

Study contacts (from the official record)

Anna Somera · 855-814-3569 · info@rhaeos.com