HydrocephalusNCT05015751
Assessment of CSF Shunt Flow With Thermal Measurements A
An observational study of Hydrocephalus, run by Rhaeos, Inc. at 4 sites in United States.
Trial summary
This study evaluates the performance of a non-invasive thermal measurement device for assessing CSF shunt flow. Patients with an existing implanted shunt and symptoms of shunt malfunction will be evaluated with the study device. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hydrocephalus
- What is being tested?
- Thermal Anisotropy Measurement Device
- Type of treatment
- Medical device
- How many people
- 44 participants
- Where
- 4 sitesUnited States
- Study dates
- 25 Aug 2021to 13 Jul 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: hydrocephalus patients with an existing ventriculoperitoneal shunt and shunt malfunction symptoms
Who may be able to join
- Existing ventriculoperitoneal CSF shunt
- At least one symptom of shunt malfunction as determined by the investigator, including seizure, fever, headache, vision problems, dizziness, disorientation, confusion, vomiting, lethargy, irritability, difficulty waking or staying awake, swelling along shunt tract, enlargement of head, loss of balance, gait disturbance, and loss of sensory or motor function
- Suspicion of shunt obstruction warrants the performance of a test for this condition in the investigator's judgement
- Region of intact skin overlying an unambiguously identifiable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device
- Available for follow-up for up to fourteen days
- Signed informed consent by patient or a parent, legal guardian, health care agent, or legally authorized representative.
- Verbal assent by minors four years of age and older who are able to understand the study and communicate their decision
Who cannot join
- Presence of multiple shunts, or presence of more than one distal shunt catheter (regardless of function) crossing the clavicle ipsilateral to the shunt with suspected obstruction
- Use of the study device would interfere with standard patient care, or emergency surgery that cannot be delayed
- Presence of an interfering open wound or edema over any portion of the shunt
- Patient-reported history of adverse skin reactions to adhesives
- Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable
- Participation in the study will interfere with, or be detrimental to, administration of optimal health-care to the subject
- Prior enrollment in this study (multiple enrollments of the same patient are disallowed)
- 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
4 sites in 1 country.
United States4 sites
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Northwestern Memorial Hospital
Chicago, Illinois, 60611
UCSF Benioff Children's Hospital - Oakland
Oakland, California, 94609
UCSF Benioff Children's Hospital
San Francisco, California, 94158
About this study
Official title: Assessment Of Flow In Cerebrospinal Fluid Shunts With A Wireless Thermal Anisotropy Measurement Device: Phase A
This study evaluates the performance of a non-invasive thermal measurement device for assessing CSF shunt flow. Patients with an existing implanted shunt and symptoms of shunt malfunction will be evaluated with the study device.
Read the detailed description
Patients with an existing implanted ventriculoperitoneal (VP) shunt and who are experiencing shunt malfunction symptoms will be recruited by the clinical investigators at each investigational site in accordance with the inclusion and exclusion criteria. Assessment of shunt flow will be performed non-invasively with the study device; physician and clinical staff will be blinded to the device result. Standard-of-care assessment of shunt function will be performed and surgical intervention will occur based on the judgement of the treating neurosurgeon without the use of study device data. This trial will evaluate the ability of the study device to identify shunt malfunctions.
- Conditions
- Hydrocephalus
- Being tested
- 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.
Thermal Anisotropy Measurement DeviceDevice
Also called FlowSense
A wireless device for non-invasively assessing CSF shunt flow.
| Study group | Role | What they receive |
|---|---|---|
| Hydrocephalus Patients | Hydrocephalus patients with an existing ventriculoperitoneal shunt and symptoms of a shunt malfunction. Receives: Device: Thermal Anisotropy Measurement Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Device Sensitivity
Study device sensitivity is calculated as TP / (TP + FN), where TP = true positive and FN = false negative.
Measured: 14-day follow-up period
Study Device Specificity
Study device specificity is calculated as TN / (TN + FP), where TN = true negative and FP = false positive.
Measured: 14-day follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start25 Aug 2021
- Primary completion13 Jul 2022
- Study completion13 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhaeos, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandi Lam, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05015751
- Sponsor's protocol ID
- 2020-01
- Status last verified
- Dec 2024
- First submitted
- 10 Aug 2021
- Last updated
- 19 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Limbrick DD Jr, Skoch J, Auguste K, Grant GA, Lam SK, Tate MC, Langer DJ, Roland JL, Alden TD, Charbel FT, Lober RM, Patten K, Kennedy E, Farless C, Himsworth S, Fasbender R, Lovell-Ewen L, Morales DM, Correia CF, Burton A, Koschnitzky JE, Webb RC, Zysk AM. A Multicenter Study of Noninvasive Wireless Assessment of Cerebrospinal Fluid Shunt Function in Hydrocephalus Patients. Neurosurgery. 2025 Dec 1;97(6):1397-1405. doi: 10.1227/neu.0000000000003569. Epub 2025 Jun 16.
PubMed 40522244
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment Of Flow In Cerebrospinal Fluid Shunts With A Wireless Thermal Anisotropy Measurement Device: Phase A
- ClinicalTrials.gov ID
- NCT05015751
- Acronym / sponsor ID
- 2020-01
- Conditions
- Hydrocephalus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Rhaeos, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Aug 2021 (actual)
- Primary completion
- 13 Jul 2022 (actual)
- Study completion
- 13 Jul 2022 (actual)
- First posted
- 20 Aug 2021 (actual)
- Results
- Posted 19 Dec 2024
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 non-invasive thermal measurement device for assessing CSF shunt flow. Patients with an existing implanted shunt and symptoms of shunt malfunction will be evaluated with the study device.
Detailed description
Patients with an existing implanted ventriculoperitoneal (VP) shunt and who are experiencing shunt malfunction symptoms will be recruited by the clinical investigators at each investigational site in accordance with the inclusion and exclusion criteria. Assessment of shunt flow will be performed non-invasively with the study device; physician and clinical staff will be blinded to the device result. Standard-of-care assessment of shunt function will be performed and surgical intervention will occur based on the judgement of the treating neurosurgeon without the use of study device data. This trial will evaluate the ability of the study device to identify shunt malfunctions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hydrocephalus Patients | – | Device: Thermal Anisotropy Measurement DeviceHydrocephalus patients with an existing ventriculoperitoneal shunt and symptoms of a shunt malfunction. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- hydrocephalus patients with an existing ventriculoperitoneal shunt and shunt malfunction symptoms
Key inclusion criteria (7 listed)
- Existing ventriculoperitoneal CSF shunt
- At least one symptom of shunt malfunction as determined by the investigator, including seizure, fever, headache, vision problems, dizziness, disorientation, confusion, vomiting, lethargy, irritability, difficulty waking or staying awake, swelling along shunt tract, enlargement of head, loss of balance, gait disturbance, and loss of sensory or motor function
- Suspicion of shunt obstruction warrants the performance of a test for this condition in the investigator's judgement
- Region of intact skin overlying an unambiguously identifiable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device
- Available for follow-up for up to fourteen days
Key exclusion criteria (8 listed)
- Presence of multiple shunts, or presence of more than one distal shunt catheter (regardless of function) crossing the clavicle ipsilateral to the shunt with suspected obstruction
- Use of the study device would interfere with standard patient care, or emergency surgery that cannot be delayed
- Presence of an interfering open wound or edema over any portion of the shunt
- Patient-reported history of adverse skin reactions to 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 |
|---|---|---|
| Thermal Anisotropy Measurement DeviceAlso: FlowSenseA wireless device for non-invasively assessing CSF shunt flow. | Device | Hydrocephalus Patients |
Primary outcome
Study Device Sensitivity
Time frame: 14-day follow-up period
Study device sensitivity is calculated as TP / (TP + FN), where TP = true positive and FN = false negative.
Study Device Specificity
Time frame: 14-day follow-up period
Study device specificity is calculated as TN / (TN + FP), where TN = true negative and FP = false positive.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40522244Limbrick DD Jr, Skoch J, Auguste K, Grant GA, Lam SK, Tate MC, Langer DJ, Roland JL, Alden TD, Charbel FT, Lober RM, Patten K, Kennedy E, Farless C, Himsworth S, Fasbender R, Lovell-Ewen L, Morales DM, Correia CF, Burton A, Koschnitzky JE, Webb RC, Zysk AM. A Multicenter Study of Noninvasive Wireless Assessment of Cerebrospinal Fluid Shunt Function in Hydrocephalus Patients. Neurosurgery. 2025 Dec 1;97(6):1397-1405. doi: 10.1227/neu.0000000000003569. Epub 2025 Jun 16.
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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.
Sandi Lam principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
4 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 4 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 7 inclusion and 8 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 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Yes. Results are posted in the registry (first posted 19 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: 14-day follow-up period). 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?
On the ClinicalTrials.gov record for NCT05015751, which also lists 1 linked publication.
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 19 Dec 2024.