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Flow Measurements in Functional CSF Shunts and Off-Shunt Locations With a Second-Generation Thermal Device
N/A
Recruiting
Research Sponsored by Rhaeos, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 1 hour
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Hydrocephalus
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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