Hydrocephalus
Conditions
Brief summary
This study evaluates the performance of the study device, FlowSense®, a sensor for non-invasively assessing cerebrospinal fluid (CSF) shunt flow. Subjects with an existing implanted ventricular CSF shunt will be evaluated with the study device in an outpatient setting to determine the negative predictive value (NPV; Part 1, blinded) and explore changes in surveillance imaging, health resource utilization, and visit duration during routine follow-up visits (Part 2, unblinded).
Interventions
The study device is a non-invasive sensor that is placed on the study subject's skin overlying an existing implanted CSF shunt. It uses an integrated thermal actuator and temperature sensors to assess shunt flow.
Sponsors
Rhaeos, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Existing ventricular cerebrospinal fluid shunt 2. Age ≥ 2 years old 3. Region of intact skin overlying an unambiguously identifiable palpable chronically indwelling ventricular shunt that crosses the clavicle; region of skin is appropriate in size for application of the study device 4. Capable of providing informed consent or have a legal guardian, health care agent, or surrogate decision-maker able to provide informed consent 5. Standard of care outpatient visit with neurosurgeon assessment of having no clinical concern for shunt malfunction
Exclusion criteria
1. Subject not scheduled to receive outpatient standard of care imaging (CT, MRI, X-ray shunt series) as part of the clinic visit 2. Presence of more than one distal shunt catheter in the study device measurement region 3. Presence of an interfering open wound or edema in the study device measurement region 4. Subject-reported history of adverse skin reactions to silicone adhesives 5. Participation in the study will interfere with, or be detrimental to, the administration of optimal health care to the subject 6. Subject not available for seven-day follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study device negative predictive value (NPV) | Up to 7 days | The study device will produce either flow confirmed or flow not confirmed data in a blinded fashion. Ground truth will be established based on 7-day follow-up an intraoperative observations for any surgery performed per the standard of care. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Study device sensitivity, specificity, diagnostic accuracy, and positive predictive value (PPV) | Up to 7 days | The study device will produce either flow confirmed or flow not confirmed data in a blinded fashion. Ground truth will be established based on 7-day follow-up an intraoperative observations for any surgery performed per the standard of care. |
Countries
United States
Contacts
Primary ContactAnna Lisa Somera
Outcome results
None listed