Flow Measurements in Functional CSF Shunts and Off-Shunt Locations with a Second-Generation Thermal Device
Completed
Conditions studied: Hydrocephalus
In brief
This study compares the performance of two generations of non-invasive cerebrospinal fluid (CSF) shunt flow assessment devices. Measurements of functional implanted shunts and off-shunt locations will assess the diagnostic non-inferiority of the second-generation device to the first-generation device.
Key facts
- Study ID
- NCT06524492
- Run by
- Rhaeos, Inc.
- People needed
- 52
- Starts
- 2024-07-25
- Expected to finish
- 2024-07-27
- Last updated by the study team
- 2025-03-11
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- A ventricular CSF shunt with a region of overlying intact skin appropriate in size for application of the study device
- Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
- Signed medical records release by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
- Verbal assent by minors 7 years of age and older who are able to understand the study and communicate their decision
You may not qualify if…
- Presence of an interfering open wound or edema in the study device measurement area
- Patient-reported history of serious adverse skin reactions to silicone-based adhesives
- Previous participation in a Rhaeos clinical study in which FlowSense device measurement data were acquired
- Patient or caregiver report of new or worsening symptoms of a possible shunt malfunction in the prior 7 days
- Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study
Where it is running
- Tampa Marriott Water Street — Tampa, Florida, United States
- Rhaeos, Inc. — Chicago, Illinois, United States
- Northwest Special Recreation Association — Rolling Meadows, Illinois, United States
Full record on ClinicalTrials.gov
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