Study of Shunt Flow Sensor Accuracy in Extra-ventricular Drains.
NCT ID: NCT01108965
Last Updated: 2016-05-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
16 participants
OBSERVATIONAL
2010-08-31
2012-05-31
Brief Summary
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The ultrasonic sensor will measure cerebrospinal fluid drainage in hydrocephalus patients with external ventriculostomies and extra-ventricular drainage systems. The sensor measurements will be compared with the volume of fluid collected by the drainage bag.
After a 24-hour measurement period, the doctor will change the drainage bag position to simulate the patient sitting up and leaning back, to see if this temporarily stops flow through the drainage line.
This data will show whether the sensor accurately measures typical drainage flows seen in hydrocephalus patients. This research will help develop an implantable flow monitor for pediatric hydrocephalus patients.
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Extraventricular Drainage
Includes hydrocephalus patients that are in recovery from shunt explanation.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Instrumented with an Extraventricular drainage system
Exclusion Criteria
* Not instrumented with an extraventricular drainage system
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Transonic Systems Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Cornelis J Drost
Role: PRINCIPAL_INVESTIGATOR
Transonic Systems Inc.
Satish Krishnamurthy, MD
Role: PRINCIPAL_INVESTIGATOR
State University of New York - Upstate Medical University
Locations
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SUNY Upstate Medical University
Syracuse, New York, United States
Countries
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Other Identifiers
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TSI-C-HYDRO-2A-H
Identifier Type: -
Identifier Source: org_study_id
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