Status:
TERMINATED
Measurements of CSF Shunts and Off-Shunt Locations With Wireless Thermal Anisotropy Measurement Devices
Lead Sponsor:
Rhaeos, Inc.
Conditions:
Hydrocephalus
Eligibility:
All Genders
Brief Summary
This study collects data using non-invasive devices for assessing CSF shunt flow using thermal anisotropy measurements in a prospective study setting. The study will collect data to compare measuremen...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- At least one existing ventricular CSF shunt, functional or non-functional (including an adjustable valve set to "virtual off," ligated shunt, uncorrected distal catheter disconnection or fracture, distal catheter fragment left in place during shunt surgery, or indication that the shunt is otherwise non-functional), with a region of overlying intact skin appropriate in size for application of the study device
- If more than one distal shunt catheter is present, at least one distal shunt catheter is at least 2 cm away from any other distal shunt catheter in the device measurement region
- 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 FlowSense device measurement area
- Patient-reported history of serious adverse skin reactions to silicone-based adhesives
- Use of the study device would interfere with standard patient care, or emergency surgery that cannot be delayed, or participation in the study will interfere with, or be detrimental to, administration of optimal healthcare to the subject
- 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 :
10 Patients enrolled
Trial Details
Trial ID
NCT06513572
Start Date
July 25 2024
End Date
July 27 2024
Last Update
May 15 2025
Active Locations (8)
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1
CHOC Commerce Tower
Orange, California, United States, 92868
2
Cedars-Sinai Accelerator
West Hollywood, California, United States, 90048
3
Tampa Marriott Water Street
Tampa, Florida, United States, 33602
4
MATTER
Chicago, Illinois, United States, 60611