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NCT07679035 · ClinicalTrials.gov registry record · NA
Study of Shunt Flow Under Different Valve Settings Using a Wireless Sensor
A NA study, sponsored by Rhaeos.
- Not yet
- Registry status
- NA
- Development phase
- 85
- Enrollment target
NCT07679035 is a NA study that has not yet begun recruiting, run by Rhaeos. The registered enrollment target is 85 participants.
The verdict
NCT07679035, a NA study, has not yet begun recruiting, sponsored by Rhaeos.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 85 participants
- Enrollment target
Study Summary
Hydrocephalus is commonly treated with a cerebrospinal fluid (CSF) shunt, a device that drains excess fluid from the brain. However, shunts can stop working over time, and determining whether fluid is flowing through a shunt can be difficult. Current diagnostic methods may require imaging studies or invasive procedures, which can be time-consuming, costly, or uncomfortable for patients. The purpose of this study is to evaluate the performance of the Rhaeos Shunt Monitoring System (RSMS), an investigational wireless, noninvasive device designed to detect flow in implanted CSF shunts. The study will compare RSMS directly with ShuntCheck III, an FDA-cleared noninvasive device that is also used to assess CSF shunt flow. Both devices are placed on the skin over the shunt and use thermal sensing technology to evaluate whether fluid is flowing through the shunt. Approximately 85 pediatric and adult participants with an existing ventricular CSF shunt will be enrolled. Participants must have a functioning shunt and no recent symptoms suggesting shunt malfunction. Some participants with programmable shunt valves will have their valve temporarily adjusted to a manufacturer-provided "virtual off" setting, which is intended to substantially restrict shunt flow. These participants may also undergo measurements at their normal valve setting. Other participants will only undergo measurements at their normal valve setting. During the study visit, participants will undergo shunt flow assessments with both RSMS and ShuntCheck III. The order in which the devices are used will be randomized. Device measurements are collected while participants are seated upright, and participants and their treating clinicians will remain blinded to the measurement results. The study devices will not be used to make treatment decisions, and participation will not alter standard medical care. Adverse events associated with device use or valve adjustments will be monitored and recorded. The primary goa
Interventions
- DEVICE Rhaeos Shunt Monitoring System (RSMS)
- DEVICE ShuntCheck III
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2026-06-30 |
| Est. Completion | 2026-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07679035
The ClinicalTrials.gov registry entry for NCT07679035 describes a study currently listed as not yet recruiting, categorized as NA. The registered enrollment target is 85 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rhaeos, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Rhaeos Shunt Monitoring System (RSMS) is the first listed.
NCT07679035 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07679035 about?
NCT07679035 is a clinical study titled "Study of Shunt Flow Under Different Valve Settings Using a Wireless Sensor". Hydrocephalus is commonly treated with a cerebrospinal fluid (CSF) shunt, a device that drains excess fluid from the brain. However, shunts can stop working over time, and determining whether fluid is flowing through a shunt can be difficult. Current diagnostic methods may require imaging studies or...
What is the current status of trial NCT07679035?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 85 participants. The study started on 2026-06-30. Estimated completion is 2026-12-31.
What interventions are being tested in trial NCT07679035?
The interventions under investigation include: Rhaeos Shunt Monitoring System (RSMS) (DEVICE), ShuntCheck III (DEVICE).
Who is sponsoring clinical trial NCT07679035?
This trial is sponsored by Rhaeos, which has 15 total clinical trials registered on ClinicalTrials.gov.
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