Sticker on the skin could detect shunt blockages without surgery

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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