Assessment of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device, Phase B
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hydrocephalus
- Sponsor
- Rhaeos, Inc.
- Enrollment
- 141
- Locations
- 9
- Primary Endpoint
- Study Device Sensitivity
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This study evaluates the performance of a non-invasive thermal measurement device for assessing CSF shunt flow. Patients with an existing implanted shunt and symptoms of shunt malfunction will be evaluated with the study device.
Detailed Description
Patients with an existing implanted ventriculoperitoneal (VP) shunt and who are experiencing shunt malfunction symptoms will be recruited by the clinical investigators at each investigational site in accordance with the inclusion and exclusion criteria. Assessment of shunt flow will be performed non-invasively with the study device; physician and clinical staff will be blinded to the device result. Standard-of-care assessment of shunt function will be performed and surgical intervention will occur based on the judgement of the treating neurosurgeon without the use of study device data. This trial will evaluate the ability of the study device to identify shunt malfunctions.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Study Device Sensitivity
Time Frame: 7-day follow-up period
Study device sensitivity is calculated as TP / (TP + FN), where TP = true positive and FN = false negative.
Study Device Specificity
Time Frame: 7-day follow-up period
Study device specificity is calculated as TN / (TN + FP), where TN = true negative and FP = false positive.