Diagnosing Malfunctioning Hydrocephalic Shunt Valves With a Flow Sensor
NCT ID: NCT00652249
Last Updated: 2012-06-05
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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WITHDRAWN
OBSERVATIONAL
2009-03-31
2010-12-31
Brief Summary
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The study will simulate an implanted shunt flow monitoring system by placing the flow sensor and a programmable shunt valve into the patient's Extra-Ventricular Drainage line. Flow will be measured as the doctor raises/lowers the drainage bag to simulate the patient sitting up/lying down. The doctor will simulate a malfunctioning shunt by changing the valve's pressure release settings for each cycle of raising/lowering the bag.
By monitoring shunt flow during these changes, the doctors hope to develop new ways to diagnose malfunctioning shunt valves when implanted shunt flow monitors become available.
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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/Pressure
Includes pediatric hydrocephalus patients that are in recovery from shunt explanation.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Newborn through age 20
* External Ventriculostomy with an Extra-Ventricular Drainage system installed
Exclusion Criteria
* Older than age 20
* No External Ventriculostomy with an Extra-Ventricular Drainage system installed
20 Years
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, BS, MS
Role: PRINCIPAL_INVESTIGATOR
Transonic Systems Inc.
Bruce A Kaufman, MD
Role: STUDY_DIRECTOR
Children's Hospital and Health System Foundation, Wisconsin
Locations
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Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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TSI-G-HYDRO-1B-H
Identifier Type: -
Identifier Source: org_study_id
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