Status:
COMPLETED
Flow Measurements in Functional CSF Shunts and Off-Shunt Locations with a Second-Generation Thermal Device
Lead Sponsor:
Rhaeos, Inc.
Conditions:
Hydrocephalus
Eligibility:
All Genders
Brief Summary
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...
Eligibility Criteria
Inclusion
- Inclusion criteria
- 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
- Exclusion criteria
- 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
Exclusion
Key Trial Info
Start Date :
July 25 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 27 2024
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT06524492
Start Date
July 25 2024
End Date
July 27 2024
Last Update
March 11 2025
Active Locations (3)
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1
Tampa Marriott Water Street
Tampa, Florida, United States, 33602
2
Rhaeos, Inc.
Chicago, Illinois, United States, 60654
3
Northwest Special Recreation Association
Rolling Meadows, Illinois, United States, 60008