HydrocephalusNCT06524492
Flow Measurements in Functional CSF Shunts and Off-Shunt Locations with a Second-Generation Thermal Device
An observational study of Hydrocephalus, run by Rhaeos, Inc. at 3 sites in United States.
Trial summary
This study compares the performance of two generations of non-invasive cerebrospinal fluid (CSF) shunt flow assessment devices. Measurements of functional implanted shunts and off-shunt locations will assess the diagnostic non-inferiority of the second-generation device to the first-generation device. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hydrocephalus
- What is being tested?
- FlowSense
- Type of treatment
- Medical device
- How many people
- 52 participants
- Where
- 3 sitesUnited States
- Study dates
- 25 Jul 2024to 27 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Pediatric and adult patients with an existing ventricular shunt will be enrolled in this study.
Who may be able to join
- A ventricular CSF shunt with a region of overlying intact skin 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)
- Signed medical records release by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
- Verbal assent by minors 7 years of age and older who are able to understand the study and communicate their decision
Who cannot join
- Presence of an interfering open wound or edema in the study device measurement area
- Patient-reported history of serious adverse skin reactions to silicone-based adhesives
- Previous participation in a Rhaeos clinical study in which FlowSense device measurement data were acquired
- Patient or caregiver report of new or worsening symptoms of a possible shunt malfunction in the prior 7 days
- 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
3 sites in 1 country.
United States3 sites
Rhaeos, Inc.
Chicago, Illinois, 60654
Northwest Special Recreation Association
Rolling Meadows, Illinois, 60008
Tampa Marriott Water Street
Tampa, Florida, 33602
About this study
Official title: Measurements of Flow in Functional Cerebrospinal Fluid Shunts and Off-Shunt Locations with a Second-Generation Wireless Thermal Anisotropy Measurement Device
This study compares the performance of two generations of non-invasive cerebrospinal fluid (CSF) shunt flow assessment devices. Measurements of functional implanted shunts and off-shunt locations will assess the diagnostic non-inferiority of the second-generation device to the first-generation device.
- Conditions
- Hydrocephalus
- Being tested
- FlowSense
- Medical subject headings
- Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlowSenseDevice
This study compares the performance of two generations of non-invasive cerebrospinal fluid (CSF) shunt flow assessment devices. Measurements of functional implanted shunts and off-shunt locations will assess the diagnostic non-inferiority of the second-generation device to the first-generation device.
| Study group | Role | What they receive |
|---|---|---|
| FlowSense | This study compares the performance of two generations of non-invasive cerebrospinal fluid (CSF) shunt flow assessment devices. Measurements of functional implanted shunts and off-shunt locations will assess the diagnostic non-inferiority of the second-generation device to the first-generation device. Receives: Device: FlowSense |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Device Sensitivity
Study device sensitivity will be calculated as TP / (TP + FN).
Measured: Approximately 1 hour
Study Device Specificity
Study device specificity will be calculated as TN / (TN + FP)
Measured: Approximately 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start25 Jul 2024
- Primary completion27 Jul 2024
- Study completion27 Jul 2024
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhaeos, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06524492
- Sponsor's protocol ID
- 2024-04
- Status last verified
- Mar 2025
- First submitted
- 23 Jul 2024
- Last updated
- 11 Mar 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 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurements of Flow in Functional Cerebrospinal Fluid Shunts and Off-Shunt Locations with a Second-Generation Wireless Thermal Anisotropy Measurement Device
- ClinicalTrials.gov ID
- NCT06524492
- Acronym / sponsor ID
- 2024-04
- Conditions
- Hydrocephalus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Rhaeos, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 27 Jul 2024 (actual)
- Study completion
- 27 Jul 2024 (actual)
- First posted
- 29 Jul 2024 (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 compares the performance of two generations of non-invasive cerebrospinal fluid (CSF) shunt flow assessment devices. Measurements of functional implanted shunts and off-shunt locations will assess the diagnostic non-inferiority of the second-generation device to the first-generation device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FlowSense | – | Device: FlowSenseThis study compares the performance of two generations of non-invasive cerebrospinal fluid (CSF) shunt flow assessment devices. Measurements of functional implanted shunts and off-shunt locations will assess the diagnostic non-inferiority of the second-generation device to the first-generation device. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pediatric and adult patients with an existing ventricular shunt will be enrolled in this study.
Key inclusion criteria (4 listed)
- A ventricular CSF shunt with a region of overlying intact skin 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)
- Signed medical records release by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
- Verbal assent by minors 7 years of age and older who are able to understand the study and communicate their decision
Key exclusion criteria (5 listed)
- Presence of an interfering open wound or edema in the study device measurement area
- Patient-reported history of serious adverse skin reactions to silicone-based adhesives
- Previous participation in a Rhaeos clinical study in which FlowSense device measurement data were acquired
- Patient or caregiver report of new or worsening symptoms of a possible shunt malfunction in the prior 7 days
- Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study
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 |
|---|---|---|
| FlowSenseThis study compares the performance of two generations of non-invasive cerebrospinal fluid (CSF) shunt flow assessment devices. Measurements of functional implanted shunts and off-shunt locations will assess the diagnostic non-inferiority of the second-generation device to the first-generation device. | Device | FlowSense |
Primary outcome
Study Device Sensitivity
Time frame: Approximately 1 hour
Study device sensitivity will be calculated as TP / (TP + FN).
Study Device Specificity
Time frame: Approximately 1 hour
Study device specificity will be calculated as TN / (TN + FP)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites 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 3 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Device Sensitivity (time frame: Approximately 1 hour). The study lists 2 primary outcomes in all. 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 11 Mar 2025.