Actively Recruiting
Detection of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Flow Detection Device During Open and Closed Shunt Periods
Led by Rhaeos, Inc. · Updated on 2026-03-18
55
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new, noninvasive wireless device that detects cerebrospinal fluid (CSF) flow through surgically implanted shunts in children and adults with hydrocephalus. The study aims to determine how well this device can distinguish between shunts that are allowing fluid flow and those that are not, without using invasive tests or imaging. Participants must already have a CSF shunt and show no new or worsening symptoms of shunt malfunction. The investigational device is a small sensor placed on the skin over the shunt tubing near the collarbone. It uses gentle warmth to measure temperature changes indicating fluid flow. All participants have measurements taken while their shunt valve is set to their usual prescribed setting. Some with programmable valves also have a second measurement after temporarily adjusting the valve to reduce or stop flow, then the valve is returned to the original setting. The device data is blinded and not used for clinical decisions. Participants are monitored during and after device use, including after any valve adjustment if applicable. Researchers collect data on device accuracy and thermal flow patterns under various conditions. Safety is closely observed, focusing on skin reactions or symptoms from valve changes. The study ends after measurements and observation, with no expected direct benefit to participants but potential future diagnostic improvements.
CONDITIONS
Brief Title
Flow Detection in Open and Closed Shunt Valve Periods
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Existing ventricular cerebrospinal fluid (CSF) shunt
- Intact skin over a clearly identifiable, palpable ventricular shunt crossing the clavicle, suitable for device placement
- Signed informed consent by the participant or legal guardian
- History of successful valve adjustments if applicable
- For participants with planned "virtual off" measurement: shunt valve programmable to a "virtual off" setting noninvasively
You will not qualify if you...
- More than one distal shunt catheter in the device measurement area
- Open wound or swelling in the device measurement region
- Shunt difficult to feel or located deeper than 5 mm from skin surface
- Shunt valve set to an opening pressure of 300 mm H2O or higher, or otherwise blocking flow
- Likely shunt independence (not requiring a functional shunt)
- More than one intact, functional distal catheter
- History of serious skin reactions to silicone-based adhesives
- New or worsening shunt malfunction symptoms in the past 7 days
- Device use would interfere with standard care or emergency surgery
- Prior enrollment in this study or participation in other conflicting investigational studies
- Previous use of the current generation study device in another Rhaeos study
- Shunt system set to substantially prevent flow for "valve normal" measurement subjects
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants undergo noninvasive assessment of cerebrospinal fluid (CSF) shunt flow using a wireless thermal flow detection device placed on the skin overlying the shunt tubing. Measurements are taken at the participant's prescribed shunt valve setting. Some participants with programmable valves capable of a "virtual off" setting will have an additional temporary valve adjustment and measurement before the valve is returned to the prescribed setting.
1 visit (in-person)
Duration - Defined follow-up period after device removal and valve readjustment
Participants are monitored for adverse events during and after device use, including any skin findings or symptoms related to valve adjustments.
Approximately 1 to 2 follow-up visits
Trial Site Locations
Total: 1 location
1
OSF Healthcare
Peoria, Illinois, United States, 61602
Actively Recruiting
Research Team
A
Anna Somera
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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