Trials / Not Yet Recruiting
Not Yet RecruitingNCT06409286
Assessment of Flow in Cerebrospinal Fluid Shunts With a Second Generation Wireless Thermal Anisotropy Measurement Device
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 17 (estimated)
- Sponsor
- Rhaeos, Inc. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This study evaluates the performance of a thermal anisotropy measurement device for non-invasively assessing CSF shunt flow. Patients with an existing implanted shunt and symptoms of shunt malfunction who require shunt revision surgery will be evaluated with the study device to assess flow in CSF shunts as confirmed by surgical outcomes at 7 days. If successful, this study will show that the study device accurately distinguishes between functioning (flowing) and non-functioning (non-flowing) shunts.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Thermal Anisotropy Measurement Device | A wireless device for non-invasively assessing CSF shunt flow |
Timeline
- Start date
- 2025-07-01
- Primary completion
- 2025-12-01
- Completion
- 2025-12-01
- First posted
- 2024-05-10
- Last updated
- 2025-05-15
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06409286. Inclusion in this directory is not an endorsement.