HydrocephalusNCT07478926
Flow Detection in Open and Closed Shunt Valve Periods
A study testing Rhaeos Shunt Monitoring System in people with Hydrocephalus, run by Rhaeos, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hydrocephalus
- What is being tested?
- Rhaeos Shunt Monitoring System
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
- Existing ventricular CSF shunt
Show all 12Show fewer
- 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)
Who cannot join
- 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
Show all 25Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
OSF Healthcare
Peoria, Illinois, 61602
Anna Somera, 855-814-3569, info@rhaeos.com
Richard Webb, PhD
About this study
Official title: Detection of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Flow Detection Device During Open and Closed Shunt Periods
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.
Read more
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.
Read the detailed description
This is a prospective, multicenter, open-label, blinded, observational study designed to evaluate the performance of a noninvasive wireless thermal flow detection device for assessing cerebrospinal fluid (CSF) shunt flow in pediatric and adult patients with hydrocephalus.
The study enrolls participants with an existing implanted ventricular CSF shunt who do not have new or worsening symptoms suggestive of shunt malfunction. The investigational device is placed externally on intact skin overlying the shunt tubing, typically near the clavicle, and measures thermal patterns associated with the presence or absence of CSF flow within the shunt catheter. Measurements are obtained using a sponsor-provided tablet application, and results are encoded so that both participants and treating clinicians remain blinded.
All participants undergo at least one device measurement with the shunt valve set to the participant's prescribed flow-permissive ("valve normal") setting. A subset of participants with programmable valves capable of being adjusted noninvasively will also undergo an additional measurement after the valve is temporarily adjusted to a manufacturer-reported "virtual off" setting, defined as a valve opening pressure exceeding 400 mm H₂O. After this measurement, the valve is returned to the prescribed setting, with confirmation using standard valve programming tools.
Participants whose valves are already prescribed at a "virtual off" setting will undergo a single measurement at that setting. A small number of initial roll-in participants are included to refine procedural logistics; their data are not included in the primary endpoint analyses.
The study is non-significant risk. The investigational device does not alter standard-of-care treatment, and device data are not used to guide clinical decision-making. Valve adjustments performed as part of the study are routinely used in clinical care and are monitored closely. Participants are observed for adverse events during device use and for a defined follow-up period after device removal and, when applicable, after valve readjustment.
The primary objective of the study is to assess the ability of the device to distinguish between flow-permissive and non-flowing shunts based on known valve settings. Secondary and exploratory objectives include evaluation of device accuracy metrics and characterization of thermal flow patterns under different conditions, such as posture changes or valve transitions.
Adverse events, including device-related skin findings and any symptoms associated with valve adjustment, are recorded and reported according to protocol and regulatory requirements. Participants exit the study after completion of the measurement(s) and required observation period.
- Conditions
- Hydrocephalus
- Being tested
- Rhaeos Shunt Monitoring System
- Keywords
- hydrocephalus, wearable, shunt, valve
- Medical subject headings
- Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhaeos Shunt Monitoring SystemDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Rhaeos Shunt Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity
Evaluation of sensitivity and specificity using the main study data
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start27 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydrocephalusStudies of the same condition, open and under way.
- More trials run by Rhaeos, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhaeos, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478926
- Sponsor's protocol ID
- 2025-04
- Status last verified
- Mar 2026
- First submitted
- 30 Jan 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Flow Detection Device During Open and Closed Shunt Periods
- ClinicalTrials.gov ID
- NCT07478926
- Acronym / sponsor ID
- 2025-04
- Conditions
- Hydrocephalus
- Keywords
- hydrocephalus, wearable, shunt, valve
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Rhaeos, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, multicenter, open-label, blinded, observational study designed to evaluate the performance of a noninvasive wireless thermal flow detection device for assessing cerebrospinal fluid (CSF) shunt flow in pediatric and adult patients with hydrocephalus.
The study enrolls participants with an existing implanted ventricular CSF shunt who do not have new or worsening symptoms suggestive of shunt malfunction. The investigational device is placed externally on intact skin overlying the shunt tubing, typically near the clavicle, and measures thermal patterns associated with the presence or absence of CSF flow within the shunt catheter. Measurements are obtained using a sponsor-provided tablet application, and results are encoded so that both participants and treating clinicians remain blinded.
All participants undergo at least one device measurement with the shunt valve set to the participant's prescribed flow-permissive ("valve normal") setting. A subset of participants with programmable valves capable of being adjusted noninvasively will also undergo an additional measurement after the valve is temporarily adjusted to a manufacturer-reported "virtual off" setting, defined as a valve opening pressure exceeding 400 mm H₂O. After this measurement, the valve is returned to the prescribed setting, with confirmation using standard valve programming tools.
Participants whose valves are already prescribed at a "virtual off" setting will undergo a single measurement at that setting. A small number of initial roll-in participants are included to refine procedural logistics; their data are not included in the primary endpoint analyses.
The study is non-significant risk. The investigational device does not alter standard-of-care treatment, and device data are not used to guide clinical decision-making. Valve adjustments performed as part of the study are routinely used in clinical care and are monitored closely. Participants are observed for adverse events during device use and for a defined follow-up period after device removal and, when applicable, after valve readjustment.
The primary objective of the study is to assess the ability of the device to distinguish between flow-permissive and non-flowing shunts based on known valve settings. Secondary and exploratory objectives include evaluation of device accuracy metrics and characterization of thermal flow patterns under different conditions, such as posture changes or valve transitions.
Adverse events, including device-related skin findings and any symptoms associated with valve adjustment, are recorded and reported according to protocol and regulatory requirements. Participants exit the study after completion of the measurement(s) and required observation period.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CSF Shunt Flow Assessment with Wireless Thermal Device | Other | Device: Rhaeos Shunt Monitoring SystemParticipants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (25 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rhaeos Shunt Monitoring Systemcharacters, 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. | Device | CSF Shunt Flow Assessment with Wireless Thermal Device |
Primary outcome
Sensitivity and Specificity
Time frame: Day 1
Evaluation of sensitivity and specificity using the main study data
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Hydrocephalus
RecruitingPhase 2
CEUS Evaluation of Hydrocephalus in Neonates and Infants
Hydrocephalus in Infants, Hydrocephalus Acquired
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
RecruitingObservational study
Natural History of Treated Neurocysticercosis and Long-Term Outcomes
Cysticercosis, Neurocysticercosis
RecruitingObservational study
Development of Non-Invasive Prenatal Diagnosis for Single Gene Disorders
Invasive PreNatal Diagnosis in a Context of Family History of Single-gene Disorders, Including, Sickle Cell Disease
Active, not recruiting
HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants
Hydrocephalus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhaeos Shunt Monitoring System in people with Hydrocephalus, run by Rhaeos, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Somera (855-814-3569, info@rhaeos.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.