NCT07478926
Flow Detection in Open and Closed Shunt Valve Periods
Recruiting
NAAll AgesInterventionalDiagnosticRhaeos, Inc.
~55 participants
Updated 2026-03-18 on ClinicalTrials.gov
What's tested:Rhaeos Shunt Monitoring System
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sensitivity and Specificity
Measured over Day 1
Conditions
Where it's being run
1 sites across 1 statesIllinois1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Existing ventricular CSF shunt with an available "virtual off" setting which can be programmed noninvasively
Region of intact skin overlying an unambiguously identifiable palpable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device
Signed informed consent by subject or a parent or legal guardian, health care agent, or surrogate decision maker (according to local statutes)
Subject-reported or documented history of successful valve adjustment(s)
Existing ventricular CSF shunt
Region of intact skin overlying an unambiguously identifiable palpable chronically indwelling ventricular shunt which crosses the clavicle and is 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)
Existing ventricular CSF shunt with an available "virtual off" setting which can be programmed noninvasively
Subject-reported or documented history of successful valve adjustment(s)
Exclusion
Presence of more than one distal shunt catheter in the study device measurement region
Presence of an interfering open wound or edema in the study device measurement region
Shunt is difficult to palpate, or the shunt depth at the device measurement location is deeper than 5 mm from the skin surface via ultrasound measurement
Shunt valve is set to an opening pressure of \>= 300 mm H2O, or the shunt system is otherwise set to substantially prevent shunt flow (e.g. Certas Plus valve programmed to a setting of 8 or a ligated shunt)
Investigator judges that the subject is likely to be shunt independent (e.g. does not require a functional shunt for management of hydrocephalus)
Subject has more than one intact and presumed functional distal catheter
Subject-reported or documented history of serious adverse skin reactions to silicone-based adhesives
Subject-reported new or worsening symptoms of a possible shunt malfunction in the prior 7 days
Use of the study device would interfere with standard patient care, or emergency surgery that cannot be delayed, or participation in the study will interfere with, or be detrimental to, administration of optimal healthcare to the subject
Prior enrollment in this study
Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study
Presence of more than one distal shunt catheter in the study device measurement region
Presence of an interfering open wound or edema in the study device measurement region
Shunt is difficult to palpate, or the shunt depth at the device measurement location is deeper than 5 mm from the skin surface via ultrasound measurement
Subject-reported or documented history of serious adverse skin reactions to silicone-based adhesives
Subject-reported new or worsening symptoms of a possible shunt malfunction in the prior 7 days
Use of the study device would interfere with standard patient care, or emergency surgery that cannot be delayed, or participation in the study will interfere with, or be detrimental to, administration of optimal healthcare to the subject
Prior enrollment in this study
Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study
Previous participation in a Rhaeos clinical study in which the study device (current generation) was used to acquire measurement data
Shunt system is set to substantially prevent shunt flow (e.g. ligated shunt)
Investigator judges that the subject is likely to be shunt independent (e.g. does not require a functional shunt for management of hydrocephalus)
Subject has more than one intact and presumed functional distal catheter
What this trial measures
- Sensitivity and SpecificityDay 1
Evaluation of sensitivity and specificity using the main study data