Assessment of CSF Shunt Flow and Headaches With a Thermal Measurement Device
ConditionHydrocephalus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-80
SponsorRhaeos, Inc.
About this trial
This study evaluates the performance of a device for non-invasively assessing cerebrospinal fluid (CSF) shunt flow over multiple measurements performed by a study subject during headache and non-headache periods.
Eligibility criteria
Qualifiers
Existing ventriculoperitoneal CSF shunt
Subject experiencing ongoing headaches including at least 15 headache days per month for the past 3 months
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
Available for remote and in-person follow-up during the 30-day measurement period
Disqualifiers
Presence of more than one distal shunt catheter in the study device measurement region
Shunt is not palpable due to depth or depth of shunt where the device will be placed is greater than 4 mm per ultrasound evaluation
Presence of an interfering open wound or edema in the study device measurement region
Subject-reported history of serious adverse skin reactions to silicone-based adhesives
Trial design
Treatments tested in this trial
- wireless thermal anisotropy measurement device
Treatment groups
29 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov