HydrocephalusNCT06996600
Assessment of CSF Shunt Flow and Headaches With a Thermal Measurement Device
A study testing wireless thermal anisotropy measurement device in people with Hydrocephalus, run by Rhaeos, Inc. at 1 site 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 headache and non-headache periods. Read more about this study
- Who is it for?
- Ages 6 to 80 years
- 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
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2025to Dec 2025
- 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 6 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Existing ventriculoperitoneal CSF shunt
- Subject experiencing ongoing headaches including at least 15 headache days per month for the past 3 months
- 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
- Available for remote and in-person follow-up during the 30-day measurement period
- Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
- Subject or caregiver is able to clearly communicate and document information and shunt symptoms in English
- Subject is at least 6 years old but not more than 80 years old
Who cannot join
- Presence of more than one distal shunt catheter in the study device measurement region
- Shunt is not palpable due to depth 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
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- Investigator judges that the subject/subject's caretaker would not be able to successfully place the device without assistance
- 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
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
Rhaeos, Inc
Chicago, Illinois, 60642
Anna Somera, 855-814-3569, clinical@rhaeos.com
About this study
Official title: Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device in People With Chronic Headaches
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 headache and non-headache periods.
- 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
| Study group | Role | What they receive |
|---|---|---|
| CSF Shunted Patients with Chronic Headaches | Experimental | hydrocephalus patients with an existing ventriculoperitoneal (VP) shunt who experience chronic headaches, defined as ≥15 headache episodes/month for ≥3 months Receives: Device: wireless thermal anisotropy measurement device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Between Study Device Flow Measurement and Subject-reported Headaches
Exploratory analysis to determine the relationship between headaches (subject-reported headache and non-headache periods) and measured flow. Data will be analyzed using the Point-Biserial Correlation Coefficient between headaches periods (headache and non-headache periods) and thermal flow score (flow score derived from algorithm analysis of raw thermal data)
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 posted30 May 2025
- Study start2 May 2025
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 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
- NCT06996600
- Sponsor's protocol ID
- 2025-01
- Status last verified
- May 2025
- First submitted
- 12 May 2025
- Last updated
- 30 May 2025
- 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 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device in People With Chronic Headaches
- ClinicalTrials.gov ID
- NCT06996600
- Acronym / sponsor ID
- 2025-01
- Conditions
- Hydrocephalus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Rhaeos, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 May 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 30 May 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 headache and non-headache periods.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CSF Shunted Patients with Chronic Headaches | Experimental | Device: wireless thermal anisotropy measurement devicehydrocephalus patients with an existing ventriculoperitoneal (VP) shunt who experience chronic headaches, defined as ≥15 headache episodes/month for ≥3 months |
Who may qualify
- Ages
- 6 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Existing ventriculoperitoneal CSF shunt
- Subject experiencing ongoing headaches including at least 15 headache days per month for the past 3 months
- 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
- Available for remote and in-person follow-up during the 30-day measurement period
- Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
Key exclusion criteria (10 listed)
- Presence of more than one distal shunt catheter in the study device measurement region
- Shunt is not palpable due to depth 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
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 | Device | CSF Shunted Patients with Chronic Headaches |
Primary outcome
Correlation Between Study Device Flow Measurement and Subject-reported Headaches
Time frame: 30 days
Exploratory analysis to determine the relationship between headaches (subject-reported headache and non-headache periods) and measured flow. Data will be analyzed using the Point-Biserial Correlation Coefficient between headaches periods (headache and non-headache periods) and thermal flow score (flow score derived from algorithm analysis of raw thermal 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 30 May 2025.
- 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.
1 site 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 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 7 inclusion and 10 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 30 May 2025. 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, clinical@rhaeos.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between Study Device Flow Measurement and Subject-reported Headaches (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 30 May 2025.