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Clinical Trials/NCT06524492
NCT06524492
Completed
Not Applicable

Measurements of Flow in Functional Cerebrospinal Fluid Shunts and Off-Shunt Locations with a Second-Generation Wireless Thermal Anisotropy Measurement Device

Rhaeos, Inc.3 sites in 1 country52 target enrollmentJuly 25, 2024
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ConditionsHydrocephalus

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hydrocephalus
Sponsor
Rhaeos, Inc.
Enrollment
52
Locations
3
Primary Endpoint
Study Device Specificity
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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 assess the diagnostic non-inferiority of the second-generation device to the first-generation device.

Registry
clinicaltrials.gov
Start Date
July 25, 2024
End Date
July 27, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Study Device Specificity

Time Frame: Approximately 1 hour

Study device specificity will be calculated as TN / (TN + FP)

Study Device Sensitivity

Time Frame: Approximately 1 hour

Study device sensitivity will be calculated as TP / (TP + FN).

Study Sites (3)

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