CompletedNCT05015751Updated Dec 19, 2024Results posted

Assessment of CSF Shunt Flow With Thermal Measurements A

An observational study in Hydrocephalus, sponsored by Rhaeos, Inc.. Completed at 4 sites in United States. Per ClinicalTrials.gov, last updated 2024-12-19.

Sponsored by Rhaeos, Inc. · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 44
Sex: All

Study 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 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 studied

Hydrocephalus

Browse trials for

Hydrocephalus 190

In context

Hydrocephalus

190 studies on the registry are indexed under Hydrocephalus; 52 are open to participants now.

This study's enrollment of 44 is below the median of 73 across 86 observational studies indexed under Hydrocephalus.

Browse Hydrocephalus studies →

Lead sponsor

Rhaeos, Inc. is the lead sponsor of 16 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

hydrocephalus patients with an existing ventriculoperitoneal shunt and shunt malfunction symptoms

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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 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

Exclusion criteria

Exclusion Criteria:

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 procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 44 participants (actual)
Patient registry: No

Groups and cohorts

Hydrocephalus Patients
Hydrocephalus patients with an existing ventriculoperitoneal shunt and symptoms of a shunt malfunction.
Device: Thermal Anisotropy Measurement Device

Interventions

DeviceThermal Anisotropy Measurement Device
A wireless device for non-invasively assessing CSF shunt flow.
Also known as: FlowSense

What researchers measure

Primary outcomes

Study Device Sensitivity
Study device sensitivity is calculated as TP / (TP + FN), where TP = true positive and FN = false negative.
Time frame: 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.
Time frame: 14-day follow-up period

Results

Posted Dec 19, 2024

Participant flow

Participant flow — Overall Study
Milestone	Hydrocephalus Patients
Started	44
Completed	40
Not completed	4

Outcome measures

PrimaryStudy Device Sensitivity

Study device sensitivity is calculated as TP / (TP + FN), where TP = true positive and FN = false negative.

Time frame:: 14-day follow-up period
Reported as:: Number · percent

Study Device Sensitivity
percent	Hydrocephalus Patients
Study Device Sensitivity	88

PrimaryStudy Device Specificity

Study device specificity is calculated as TN / (TN + FP), where TN = true negative and FP = false positive.

Time frame:: 14-day follow-up period
Reported as:: Number · percent

Study Device Specificity
percent	Hydrocephalus Patients
Study Device Specificity	87

Adverse events

Collected over 20 minutes. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Hydrocephalus Patients	0/44 (0%)	0/44 (0%)	0/44 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Hydrocephalus Patients
Mean	22 ± 19

Sex: Female, Male
Sex: Female, Male(Participants)	Hydrocephalus Patients
Female	26
Male	18

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Hydrocephalus Patients
Hispanic or Latino	11
Not Hispanic or Latino	31
Unknown or Not Reported	2

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Hydrocephalus Patients
Race — American Indian or Alaska Native	0
Race — Asian	3
Race — Native Hawaiian or Other Pacific Islander	0
Race — Black or African American	3
Race — White	26
Race — More than one Race	1
Race — Other	3
Race — Unknown or Not Reported	8

Study locations

4 sites

UCSF Benioff Children's Hospital - Oakland
Oakland, California 94609, United States
UCSF Benioff Children's Hospital
San Francisco, California 94158, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois 60611, United States
Northwestern Memorial Hospital
Chicago, Illinois 60611, United States

References and documents

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 documents

Protocol and statistical analysis plan ↗ · Feb 18, 2023

PDFs hosted by the registry, ClinicalTrials.gov.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2021 to primary completion in Jul 2022, 10 months.

Results were first posted in Dec 2024, 2 years 5 months after primary completion.

Of 37 observational studies under Hydrocephalus, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 81. This study's 10 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered: Aug 10, 2021
First posted: Aug 20, 2021
StartActual: Aug 25, 2021
Primary completionActual: Jul 13, 2022
CompletionActual: Jul 13, 2022
Results first posted: Dec 19, 2024
Last update: Dec 19, 2024

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Dec 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05015751
Lead sponsor: Rhaeos, Inc.
Responsible party: Sponsor
First posted: Aug 20, 2021
Start date: Aug 25, 2021
Primary completion: Jul 13, 2022
Completion: Jul 13, 2022
Results posted: Dec 19, 2024
Last update: Dec 19, 2024

Study contacts

Sandi Lam

principal investigator · Ann & Robert H Lurie Children's Hospital of Chicago

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hydrocephalus →

Other studies from this sponsor

Rhaeos, Inc.

Start the discussion