HydrocephalusNCT06040697
Formative Usability Assessment of Wireless Thermal Anisotropy Devices
An observational study of Hydrocephalus, run by Rhaeos, Inc. at 1 site in United States.
Trial summary
Measurements of shunt flow will be performed non-invasively. This study will generate usability data via observed tasks and comprehension questions to enable future device design improvements. Read more about this study
- Who is it for?
- Ages 5 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hydrocephalus
- What is being tested?
- Thermal Anisotropy
- Type of treatment
- Medical device
- How many people
- 145 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2023to Dec 2025
- Phase
- Observational
- 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 5 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Subjects with an existing Cerebrospinal Fluid (CSF) shunt
Who may be able to join
- Existing ventricular CSF shunt with a region of intact skin overlying the shunt catheter 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 or caregiver can clearly communicate and document information in English
- Verbal assent by minors 12 years of age and older who can understand the study and communicate their decision
- Subject is at least 5 years old but not more than 80 years old
Who cannot join
- Presence of an interfering open wound in the device application region
- Subject-reported history of adverse skin reactions to adhesives
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, 60654
Anna Somera, clinical@rhaeos.com
About this study
Official title: Formative Usability Assessment of Wireless Thermal Anisotropy Devices Measuring Flow in Cerebrospinal Fluid Shunts
Measurements of shunt flow will be performed non-invasively. This study will generate usability data via observed tasks and comprehension questions to enable future device design improvements.
- Conditions
- Hydrocephalus
- Being tested
- Thermal Anisotropy
- Medical subject headings
- Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal AnisotropyDevice
Also called FlowSense
Usability assessment observation.
| Study group | Role | What they receive |
|---|---|---|
| Usability Assessment Cohort | No interventions administered. Device usability assessment only. Receives: Device: Thermal Anisotropy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exploratory device usability feedback
Identification of usability risks [unscored]
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start29 Sep 2023
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 145 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
- NCT06040697
- Sponsor's protocol ID
- 2023-02
- Status last verified
- May 2025
- First submitted
- 31 Aug 2023
- Last updated
- 15 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 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Formative Usability Assessment of Wireless Thermal Anisotropy Devices Measuring Flow in Cerebrospinal Fluid Shunts
- ClinicalTrials.gov ID
- NCT06040697
- Acronym / sponsor ID
- 2023-02
- Conditions
- Hydrocephalus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- Rhaeos, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Sep 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 15 Sep 2023 (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.
Measurements of shunt flow will be performed non-invasively. This study will generate usability data via observed tasks and comprehension questions to enable future device design improvements.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Usability Assessment Cohort | – | Device: Thermal AnisotropyNo interventions administered. Device usability assessment only. |
Who may qualify
- Ages
- 5 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects with an existing Cerebrospinal Fluid (CSF) shunt
Key inclusion criteria (5 listed)
- Existing ventricular CSF shunt with a region of intact skin overlying the shunt catheter 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 or caregiver can clearly communicate and document information in English
- Verbal assent by minors 12 years of age and older who can understand the study and communicate their decision
- Subject is at least 5 years old but not more than 80 years old
Key exclusion criteria (2 listed)
- Presence of an interfering open wound in the device application region
- Subject-reported history of adverse skin reactions to adhesives
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 |
|---|---|---|
| Thermal AnisotropyAlso: FlowSenseUsability assessment observation. | Device | Usability Assessment Cohort |
Primary outcome
Exploratory device usability feedback
Time frame: 2 hours
Identification of usability risks [unscored]
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 15 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?
An observational study of 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 5 inclusion and 2 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 15 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, info@rhaeos.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exploratory device usability feedback (time frame: 2 hours). 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 15 May 2025.