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FlowSense for Obstructive Hydrocephalus

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
  • Obstructive Hydrocephalus
  • Hydrocephalus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 1 hour
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 1 hour for reporting.

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
~0 spots leftby Dec 2024
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