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NCT06409286 · ClinicalTrials.gov registry record
Assessment of Flow in Cerebrospinal Fluid Shunts With a Second Generation Wireless Thermal Anisotropy Measurement Device
A clinical trial, sponsored by Rhaeos.
- Not yet
- Registry status
- 17
- Enrollment target
NCT06409286: Clinical Trial study, sponsored by Rhaeos.
NCT06409286 is a clinical trial that has not yet begun recruiting, run by Rhaeos. The registered enrollment target is 17 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06409286 has not yet begun recruiting, sponsored by Rhaeos.
- NOT YET RECRUITING
- Registry status
- 17 participants
- Enrollment target
Study 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.
Primary Outcome
The study device will yield an output of either "flow confirmed" or "flow not confirmed." Based on this assessment and the standard-of-care clinical treatment, each subject will fall into one of the following categories: True Positive (TP): Device outputs "flow not confirmed" AND a shunt revision surgery with confirmed shunt failure is performed False Positive (FP): Device outputs "flow not confirmed" AND either no shunt revision surgery is performed for 7 days or a shunt revision surgery witho
Interventions
- DEVICE Thermal Anisotropy Measurement Device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2025-07 |
| Est. Completion | 2025-12 |
What is known before NCT06409286 opens enrollment
NCT06409286 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 17 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Thermal Anisotropy Measurement Device is the first listed.
NCT06409286 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06409286 about?
NCT06409286 is a clinical study titled "Assessment of Flow in Cerebrospinal Fluid Shunts With a Second Generation Wireless Thermal Anisotropy Measurement Device". 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 sh...
What is the current status of trial NCT06409286?
This trial is currently not yet recruiting. The enrollment target is 17 participants. The study started on 2025-07. Estimated completion is 2025-12.
What interventions are being tested in trial NCT06409286?
The interventions under investigation include: Thermal Anisotropy Measurement Device (DEVICE).
Who is sponsoring clinical trial NCT06409286?
This trial is sponsored by Rhaeos, which has 15 total clinical trials registered on ClinicalTrials.gov.
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