Flow Measurements in Functional CSF Shunts and Off-Shunt Locations with a Second-Generation Thermal Device
Completed
- Conditions
- Hydrocephalus
- Interventions
- Device: FlowSense
- Registration Number
- NCT06524492
- Lead Sponsor
- Rhaeos, Inc.
- Brief Summary
This study compares the performance of two generations of non-invasive cerebrospinal fluid (CSF) shunt flow assessment devices. Measurements of functional implanted shunts and off-shunt locations will assess the diagnostic non-inferiority of the second-generation device to the first-generation device.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description FlowSense FlowSense This study compares the performance of two generations of non-invasive cerebrospinal fluid (CSF) shunt flow assessment devices. Measurements of functional implanted shunts and off-shunt locations will assess the diagnostic non-inferiority of the second-generation device to the first-generation device.
- Primary Outcome Measures
Name Time Method Study Device Specificity Approximately 1 hour Study device specificity will be calculated as TN / (TN + FP)
Study Device Sensitivity Approximately 1 hour Study device sensitivity will be calculated as TP / (TP + FN).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Tampa Marriott Water Street
🇺🇸Tampa, Florida, United States
Rhaeos, Inc.
🇺🇸Chicago, Illinois, United States
Northwest Special Recreation Association
🇺🇸Rolling Meadows, Illinois, United States