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Flow Measurements in Functional CSF Shunts and Off-Shunt Locations with a Second-Generation Thermal Device

NCT06524492 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 52

Last updated 2025-03-11

No results posted yet for this study

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.

Conditions

  • Hydrocephalus

Interventions

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.

Sponsors & Collaborators

  • Rhaeos, Inc.

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-25
Primary Completion
2024-07-27
Completion
2024-07-27
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06524492 on ClinicalTrials.gov