💬In plain words
What the trial is, and whether it could suit you
This study is evaluating a new, noninvasive device designed to detect whether cerebrospinal fluid (CSF) is flowing through a surgically implanted shunt. CSF shunts are commonly used to treat hydrocephalus, but it can be difficult to tell whether a shunt is working properly without invasive testing or imaging that does not directly measure flow.
The study device is a small, wireless sensor placed on the skin over the shunt tubing, typically near the collarbone. It uses gentle, controlled warmth to measure temperature changes that indicate whether fluid is flowing inside the shunt. The device does not break the skin and does not change a participant's medical care.
This study will enroll children and adults who already have a CSF shunt and who do not have new or worsening symptoms of shunt malfunction. All participants will have a measurement taken while their shunt valve is at its usual
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
Inclusion and Exclusion Criteria for Roll-In Subjects Inclusion criteria
* 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)
Inclusion and Exclusion Criteria for Main Study Subjects
Inclusion criteria
* 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)
Subjects with planned "virtual off" measurement:
-Existing ventricular CSF shunt with an available "virtual off" setting which can be programmed noninvasively
Subjects with planned adjustment to the "virtual off" setting only:
-Subject-reported or documented history of successful valve adjustment(s)
Exclusion Criteria:
Exclusion criteria
* 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
Exclusion Criteria for Main Study Subjects Exclusion criteria
* 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
Subjects with planned "valve normal" measurements:
* 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
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