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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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 1 hour
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 1 hour
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Study Device Sensitivity
Study Device Specificity
Trial Design
1Treatment groups
Experimental Treatment
Group I: FlowSenseExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Rhaeos, Inc.Lead Sponsor
9 Previous Clinical Trials
616 Total Patients Enrolled
9 Trials studying Hydrocephalus
616 Patients Enrolled for Hydrocephalus
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