Trials / Completed
CompletedNCT06524492
Flow Measurements in Functional CSF Shunts and Off-Shunt Locations with a Second-Generation Thermal Device
Measurements of Flow in Functional Cerebrospinal Fluid Shunts and Off-Shunt Locations with a Second-Generation Wireless Thermal Anisotropy Measurement Device
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 52 (actual)
- Sponsor
- Rhaeos, Inc. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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. |
Timeline
- Start date
- 2024-07-25
- Primary completion
- 2024-07-27
- Completion
- 2024-07-27
- First posted
- 2024-07-29
- Last updated
- 2025-03-11
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06524492. Inclusion in this directory is not an endorsement.