Hydrocephalus
Conditions
Brief summary
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
Interventions
Wireless wearable thermal anisotropy measurement device designed for use at home will be provided to study subjects in both study arms
Sponsors
Rhaeos, Inc.
National Institute of Neurological Disorders and Stroke (NINDS)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Existing ventricular CSF shunt 2. (Cohort A) A history of stable ventricular size, no shunt revision in the previous 2 years, and no current symptoms of shunt failure 3. (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 4. 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 5. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes) 6. Subject is at least 5 years old but \< 22 years old
Exclusion criteria
1. Shunt is not palpable or depth of shunt where the device will be placed is greater than 4 mm per ultrasound evaluation 2. Presence of an interfering open wound or edema in the study device measurement region 3. Subject-reported history of serious adverse skin reactions to silicone-based adhesives 4. Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable 5. Investigator judges that the subject is unlikely to successfully take reliable measurements at home 6. Investigator judges that the subject/subject's caretaker would not be able to successfully place the device without assistance 7. 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 8. Prior enrollment in this study 9. Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Device Effects | 30 days | The co-primary endpoints in this study are the rate of ADEs and SADEs that occur per wear hour. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ADEs and SADEs per wear period | 30 days | rate of ADEs and SADEs per wear period |
| ADEs and SADEs per subject | 30 days | rate of ADEs and SADEs per subject; |
| ADEs and SADEs that preclude the continued use of the study device | 30 days | rate of ADEs and SADEs that preclude the continued use of the study device |
| Device deficiencies resulting in incomplete monitoring data | 30 days | percent of device deficiencies resulting in incomplete monitoring data |
| Local skin reactions per wear session; | 30 days | number of local skin reactions per wear session; |
| Usability score | 30 days | usability score based on post-study survey (1 = easy to use; 5 = difficult to use) |
Countries
United States
Contacts
CONTACTRichard C Webb, PhD
Outcome results
None listed