Health TrialsbyHealthPanel

Assessment of CSF Shunt Flow During Activities of Daily Living and Sleep With a Thermal Measurement Device

ConditionHydrocephalus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2+
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 activities of daily living and sleep

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Existing ventricular CSF shunt

(Cohort A) A history of stable ventricular size, no shunt revision in the previous 2 years, and no current symptoms of shunt failure

(Cohort B) A shunt revision in the previous 7 days and the investigator judges that the patient will likely be discharged within 4 days of the enrollment date

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

Disqualifiers

Shunt is not palpable 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

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • wireless thermal anisotropy measurement device

    Device

    Wireless wearable thermal anisotropy measurement device designed for use at home will be provided to study subjects in both study arms

Treatment groups

28 Participants
are divided into 2 treatment groups
Group A: No Recent RevisionExperimental treatment 1 intervention
Group B: Recent RevisionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse Device Effects

The co-primary endpoints in this study are the rate of ADEs and SADEs that occur per wear hour.

Time frame
30 days

Secondary outcomes

1

ADEs and SADEs per wear period

rate of ADEs and SADEs per wear period

Time frame
30 days
2

ADEs and SADEs per subject

rate of ADEs and SADEs per subject;

Time frame
30 days
3

ADEs and SADEs that preclude the continued use of the study device

rate of ADEs and SADEs that preclude the continued use of the study device

Time frame
30 days
4

Device deficiencies resulting in incomplete monitoring data

percent of device deficiencies resulting in incomplete monitoring data

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rhaeos, Inc.

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Source ClinicalTrials.gov
Apply now