HydrocephalusNCT07050628
Assessment of CSF Shunt Flow During Activities of Daily Living and Sleep With a Thermal Measurement Device
A study testing wireless thermal anisotropy measurement device in people with Hydrocephalus, run by Rhaeos, Inc. at 2 sites in United States.
Trial summary
This study evaluates the performance of a device for non-invasively assessing cerebrospinal fluid (CSF) shunt flow over multiple measurements performed by a study subject during activities of daily living and sleep Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Hydrocephalus
- What is being tested?
- wireless thermal anisotropy measurement device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Nov 2025to 30 Jun 2027
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Existing ventricular CSF shunt
- (Cohort A) A history of stable ventricular size, no shunt revision in the previous 2 years, and no current symptoms of shunt failure
- (Cohort B) A shunt revision in the previous 7 days and the investigator judges that the patient will likely be discharged within 4 days of the enrollment date
- 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)
- Subject is at least 5 years old but < 22 years old
Who cannot join
- Shunt is not palpable or depth of shunt where the device will be placed is greater than 4 mm per ultrasound evaluation
- Presence of an interfering open wound or edema in the study device measurement region
- Subject-reported history of serious adverse skin reactions to silicone-based adhesives
- Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable
- Investigator judges that the subject is unlikely to successfully take reliable measurements at home
- Investigator judges that the subject/subject's caretaker would not be able to successfully place the device without assistance
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Rhaeos Inc.
Chicago, Illinois, 60642
Anna Somera, 855-814-3569, clinical@rhaeos.com
- Recruiting
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298
Lisa Merck, 804-628-8995, Lisa.Merck@vcuhealth.org
About this study
Official title: Long-Term Tracking of Fluid Dynamics in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device During Activities of Daily Living Including Sleep
This study evaluates the performance of a device for non-invasively assessing cerebrospinal fluid (CSF) shunt flow over multiple measurements performed by a study subject during activities of daily living and sleep
- Conditions
- Hydrocephalus
- Being tested
- wireless thermal anisotropy measurement device
- Medical subject headings
- Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wireless thermal anisotropy measurement deviceDevice
Wireless wearable thermal anisotropy measurement device designed for use at home will be provided to study subjects in both study arms
| Study group | Role | What they receive |
|---|---|---|
| No Recent Revision | Experimental | Pediatric hydrocephalus patients with an existing ventricular CSF shunt and a history of stable ventricular size, no shunt revision in the previous 2 years, and no current symptoms of shunt failure will be enrolled. Receives: Device: wireless thermal anisotropy measurement device |
| Recent Revision | Experimental | Pediatric hydrocephalus patients with an existing ventricular CSF shunt and a shunt revision in the previous 7 days who the investigator judges will likely be discharged within 4 days of the enrollment date will be enrolled. Receives: Device: wireless thermal anisotropy measurement device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Device Effects
The co-primary endpoints in this study are the rate of ADEs and SADEs that occur per wear hour.
Measured: 30 days
Secondary outcomes (6)
ADEs and SADEs per wear period
rate of ADEs and SADEs per wear period
Measured: 30 days
ADEs and SADEs per subject
rate of ADEs and SADEs per subject;
Measured: 30 days
ADEs and SADEs that preclude the continued use of the study device
rate of ADEs and SADEs that preclude the continued use of the study device
Measured: 30 days
Device deficiencies resulting in incomplete monitoring data
percent of device deficiencies resulting in incomplete monitoring data
Measured: 30 days
Local skin reactions per wear session;
number of local skin reactions per wear session;
Measured: 30 days
Usability score
usability score based on post-study survey (1 = easy to use; 5 = difficult to use)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start10 Nov 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion30 Jun 2027 (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
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 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
- NCT07050628
- Sponsor's protocol ID
- 2025-03
- Other IDs
- 5UG3NS130338
- Status last verified
- Aug 2026
- First submitted
- 25 Jun 2025
- Last updated
- 25 Aug 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 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Tracking of Fluid Dynamics in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device During Activities of Daily Living Including Sleep
- ClinicalTrials.gov ID
- NCT07050628
- Acronym / sponsor ID
- 2025-03
- Conditions
- Hydrocephalus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Rhaeos, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 3 Jul 2025 (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 evaluates the performance of a device for non-invasively assessing cerebrospinal fluid (CSF) shunt flow over multiple measurements performed by a study subject during activities of daily living and sleep
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Recent Revision | Experimental | Device: wireless thermal anisotropy measurement devicePediatric hydrocephalus patients with an existing ventricular CSF shunt and a history of stable ventricular size, no shunt revision in the previous 2 years, and no current symptoms of shunt failure will be enrolled. |
| Recent Revision | Experimental | Device: wireless thermal anisotropy measurement devicePediatric hydrocephalus patients with an existing ventricular CSF shunt and a shunt revision in the previous 7 days who the investigator judges will likely be discharged within 4 days of the enrollment date will be enrolled. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Existing ventricular CSF shunt
- (Cohort A) A history of stable ventricular size, no shunt revision in the previous 2 years, and no current symptoms of shunt failure
- (Cohort B) A shunt revision in the previous 7 days and the investigator judges that the patient will likely be discharged within 4 days of the enrollment date
- 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)
Key exclusion criteria (9 listed)
- Shunt is not palpable or depth of shunt where the device will be placed is greater than 4 mm per ultrasound evaluation
- Presence of an interfering open wound or edema in the study device measurement region
- Subject-reported history of serious adverse skin reactions to silicone-based adhesives
- Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable
- Investigator judges that the subject is unlikely to successfully take reliable measurements at home
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 |
|---|---|---|
| wireless thermal anisotropy measurement deviceWireless wearable thermal anisotropy measurement device designed for use at home will be provided to study subjects in both study arms | Device | No Recent Revision, Recent Revision |
Primary outcome
Adverse Device Effects
Time frame: 30 days
The co-primary endpoints in this study are the rate of ADEs and SADEs that occur per wear hour.
6 secondary outcomes
ADEs and SADEs per wear period
Time frame: 30 days
ADEs and SADEs per subject
Time frame: 30 days
ADEs and SADEs that preclude the continued use of the study device
Time frame: 30 days
Device deficiencies resulting in incomplete monitoring data
Time frame: 30 days
Local skin reactions per wear session;
Time frame: 30 days
Usability score
Time frame: 30 days
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 25 Aug 2026.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wireless thermal anisotropy measurement device in people with Hydrocephalus, run by Rhaeos, Inc. at 2 sites 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 6 inclusion and 9 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 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Richard C Webb, PhD (855-814-3569, cwebb@rhaeos.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Device Effects (time frame: 30 days). 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 25 Aug 2026.