Trials / Recruiting
RecruitingNCT06086561
Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- Sponsor
- Rhaeos, Inc. · Industry
- Sex
- All
- Age
- 5 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This study evaluates the performance of a device for non-invasively assessing cerebrospinal fluid (CSF) shunt flow. Patients with an existing implanted shunt will wear the device to acquire longitudinal data.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Thermal Anisotropy Measurement Device | 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. |
Timeline
- Start date
- 2023-11-17
- Primary completion
- 2025-12-01
- Completion
- 2025-12-01
- First posted
- 2023-10-17
- Last updated
- 2025-05-15
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06086561. Inclusion in this directory is not an endorsement.