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Flow Detection in Open and Closed Shunt Valve Periods
NCT07478926 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07478926
The ClinicalTrials.gov registry entry for NCT07478926 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rhaeos, which has 38 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07478926 reports 1 study location spanning 1 distinct geographic area — top geographies include Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07478926?
The interventions under investigation include: Rhaeos Shunt Monitoring System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07478926?
This trial is sponsored by Rhaeos, which has 38 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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