Flow Measurements in Functional CSF Shunts and Off-Shunt Locations with a Second-Generation Thermal Device
NCT ID: NCT06524492
Last Updated: 2025-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
52 participants
OBSERVATIONAL
2024-07-25
2024-07-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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FlowSense
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.
FlowSense
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.
Interventions
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FlowSense
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.
Eligibility Criteria
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Inclusion Criteria
2. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
3. Signed medical records release by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
4. Verbal assent by minors 7 years of age and older who are able to understand the study and communicate their decision
Exclusion Criteria
2. Patient-reported history of serious adverse skin reactions to silicone-based adhesives
3. Previous participation in a Rhaeos clinical study in which FlowSense device measurement data were acquired
4. Patient or caregiver report of new or worsening symptoms of a possible shunt malfunction in the prior 7 days
5. Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study
ALL
No
Sponsors
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Rhaeos, Inc.
INDUSTRY
Responsible Party
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Locations
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Tampa Marriott Water Street
Tampa, Florida, United States
Rhaeos, Inc.
Chicago, Illinois, United States
Northwest Special Recreation Association
Rolling Meadows, Illinois, United States
Countries
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Other Identifiers
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2024-04
Identifier Type: -
Identifier Source: org_study_id
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