HydrocephalusSTEALTHNCT05432986
Assessment of CSF Shunt Flow With Thermal Measurements B
An observational study of Hydrocephalus, run by Rhaeos, Inc. at 10 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
- 141 participants
- Where
- 10 sitesUnited States
- Study dates
- 7 Jul 2022to 10 Nov 2023
- 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 on which the patient is dependent
- At least one symptom of shunt malfunction as determined by the investigator, such as but not limited to 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 seven days
- Signed informed consent by patient or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes, and collectively referred to as "surrogates" in this protocol)
- 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 main study 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
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Lurie Children's Hospital
Chicago, Illinois, 60611
Northwestern Memorial Hospital
Chicago, Illinois, 60611
University of Illinois Chicago
Chicago, Illinois, 60612
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Dayton Children's Hospital
Dayton, Ohio, 45404
Duke University Medical Center
Durham, North Carolina, 27710
Lenox Hill Hospital
New York, New York, 10075
UCSF Benioff Children's Hospital
Oakland, California, 94609
UCSF Benioff Children's Hospital
San Francisco, California, 94158
Washington University in St. Louis
St Louis, Missouri, 63110
About this study
Official title: Assessment of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device, Phase B
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: 7-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: 7-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 posted27 Jun 2022
- Study start7 Jul 2022
- Primary completion3 Nov 2023
- Study completion10 Nov 2023
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.
- 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
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhaeos, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandi Lam, MD, MBA, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05432986
- Sponsor's protocol ID
- 2021-01
- Acronym
- STEALTH
- Status last verified
- Jan 2025
- First submitted
- 21 Jun 2022
- Last updated
- 20 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. 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 B
- ClinicalTrials.gov ID
- NCT05432986
- Acronym / sponsor ID
- STEALTH / 2021-01
- Conditions
- Hydrocephalus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Rhaeos, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 3 Nov 2023 (actual)
- Study completion
- 10 Nov 2023 (actual)
- First posted
- 27 Jun 2022 (actual)
- Results
- Posted 30 Jan 2025
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 on which the patient is dependent
- At least one symptom of shunt malfunction as determined by the investigator, such as but not limited to 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 seven 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: 7-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: 7-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 20 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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, MD, MBA principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
10 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 10 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 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 30 Jan 2025). 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: 7-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?
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 20 Feb 2025.