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NCT07478926 · ClinicalTrials.gov registry record · NA
Flow Detection in Open and Closed Shunt Valve Periods
A NA study of Hydrocephalus, sponsored by Rhaeos.
- Recruiting
- Registry status
- NA
- Development phase
- 55
- Enrollment target
- 1
- Study location
NCT07478926: Recruiting NA study of Hydrocephalus, sponsored by Rhaeos.
NCT07478926 is a NA study of Hydrocephalus that is actively recruiting participants, run by Rhaeos. The registered enrollment target is 55 participants, below the 130-participant average among 17 other Hydrocephalus trials with a reported enrollment target (58% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07478926, a NA study of Hydrocephalus, is actively recruiting participants, sponsored by Rhaeos.
- RECRUITING
- Registry status
- NA
- Development phase
- 55 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is evaluating a new, noninvasive device designed to detect whether cerebrospinal fluid (CSF) is flowing through a surgically implanted shunt. CSF shunts are commonly used to treat hydrocephalus, but it can be difficult to tell whether a shunt is working properly without invasive testing or imaging that does not directly measure flow. The study device is a small, wireless sensor placed on the skin over the shunt tubing, typically near the collarbone. It uses gentle, controlled warmth to measure temperature changes that indicate whether fluid is flowing inside the shunt. The device does not break the skin and does not change a participant's medical care. This study will enroll children and adults who already have a CSF shunt and who do not have new or worsening symptoms of shunt malfunction. All participants will have a measurement taken while their shunt valve is at its usual prescribed setting. Some participants with programmable shunt valves will also have a second measurement taken after their valve is temporarily adjusted to a setting intended to stop or greatly reduce flow ("virtual off"). After this measurement, the valve will be returned to its prescribed setting. The study device results will not be shown to participants or their medical providers and will not be used to make treatment decisions. The goal of the study is to determine how well the device can distinguish between shunts that are allowing flow and those that are not. Participants will be monitored for a short period after device use and, if applicable, after any valve adjustment. The main risks of participation are mild skin irritation from the adhesive or temporary symptoms related to valve adjustment. Participants are not expected to receive a direct medical benefit, but the information gained may help improve future diagnosis of shunt function.
Primary Outcome
Evaluation of sensitivity and specificity using the main study data
Conditions Studied
Interventions
- DEVICE Rhaeos Shunt Monitoring System
Study Locations (1)
Illinois
- OSF Healthcare - Peoria
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2026-01-27 |
| Est. Completion | 2026-12-31 |
| Phase | NA |
What NCT07478926 shows while recruiting
NCT07478926 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 130-participant average among 17 other Hydrocephalus trials with a reported enrollment target (58% lower).
The record links to 1 condition, with Hydrocephalus appearing as the primary indexed condition, and to 1 intervention - of which Rhaeos Shunt Monitoring System is the first listed.
NCT07478926 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT07478926 about?
NCT07478926 is a clinical study titled "Flow Detection in Open and Closed Shunt Valve Periods". This study is evaluating a new, noninvasive device designed to detect whether cerebrospinal fluid (CSF) is flowing through a surgically implanted shunt. CSF shunts are commonly used to treat hydrocephalus, but it can be difficult to tell whether a shunt is working properly without invasive testing o...
What is the current status of trial NCT07478926?
This trial is currently recruiting. It is a NA study. The enrollment target is 55 participants. The study started on 2026-01-27. Estimated completion is 2026-12-31.
What conditions does trial NCT07478926 study?
This clinical trial studies the following conditions: Hydrocephalus.
What interventions are being tested in trial NCT07478926?
The interventions under investigation include: Rhaeos Shunt Monitoring System (DEVICE).
Who is sponsoring clinical trial NCT07478926?
This trial is sponsored by Rhaeos, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07478926 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hydrocephalus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07478926's enrollment target sits among peer trials
55 11th of 17 higher than 7 of 17 other Hydrocephalus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hydrocephalus 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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MR Evaluation of Cerebrospinal Fluid (CSF) Dynamics
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-
US Pilot Study of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus
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