Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device

ConditionHydrocephalus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-80
SponsorRhaeos, Inc.

About this trial

This study evaluates the performance of a device for non-invasively assessing cerebrospinal fluid (CSF) shunt flow. Patients with an existing implanted shunt will wear the device to acquire longitudinal data.

Eligibility criteria

Qualifiers

At least one existing ventricular CSF shunt (functional or non-functional, including "virtual off" and ligated, orphaned, abandoned, tied-off, or fractured distal catheters)

Region(s) of intact skin overlying at least one unambiguously identifiable 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 (for subjects using the study device at home)

Subject is expected to remain in an inpatient setting for sufficient time to complete all required study device measurements (for subjects using the device in an inpatient hospital setting)

Disqualifiers

Presence of an interfering open wound or edema over any portion of the shunt

Patient-reported history of adverse skin reactions to adhesives

Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable

Investigator judges that the subject is unlikely to successfully take reliable measurements at home (for subjects using the study device at home)

Trial design

Treatments tested in this trial

  • Thermal Anisotropy Measurement Device

Treatment groups

130 Participants
are divided into 1 treatment group

Sponsors and collaborators