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NCT06410885 · ClinicalTrials.gov registry record · NA
Assessment of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device in Asymptomatic Patients
A NA study, sponsored by Rhaeos.
- Not yet
- Registry status
- NA
- Development phase
- 60
- Enrollment target
NCT06410885: Clinical Trial NA study, sponsored by Rhaeos.
NCT06410885 is a NA study that has not yet begun recruiting, run by Rhaeos. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06410885, a NA study, has not yet begun recruiting, sponsored by Rhaeos.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
Study Summary
This study evaluates the performance of the study device, FlowSense®, a sensor for non-invasively assessing cerebrospinal fluid (CSF) shunt flow. Subjects with an existing implanted ventricular CSF shunt will be evaluated with the study device in an outpatient setting to determine the negative predictive value (NPV; Part 1, blinded) and explore changes in surveillance imaging, health resource utilization, and visit duration during routine follow-up visits (Part 2, unblinded).
Primary Outcome
The study device will produce either "flow confirmed" or "flow not confirmed" data in a blinded fashion. Ground truth will be established based on 7-day follow-up an intraoperative observations for any surgery performed per the standard of care.
Interventions
- DEVICE Thermal Anisotropy Measurement Device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-06 |
| Est. Completion | 2026-05 |
| Phase | NA |
What is known before NCT06410885 opens enrollment
NCT06410885 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Thermal Anisotropy Measurement Device is the first listed.
NCT06410885 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06410885 about?
NCT06410885 is a clinical study titled "Assessment of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device in Asymptomatic Patients". This study evaluates the performance of the study device, FlowSense®, a sensor for non-invasively assessing cerebrospinal fluid (CSF) shunt flow. Subjects with an existing implanted ventricular CSF shunt will be evaluated with the study device in an outpatient setting to determine the negative predi...
What is the current status of trial NCT06410885?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2025-06. Estimated completion is 2026-05.
What interventions are being tested in trial NCT06410885?
The interventions under investigation include: Thermal Anisotropy Measurement Device (DEVICE).
Who is sponsoring clinical trial NCT06410885?
This trial is sponsored by Rhaeos, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06410885's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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