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Diagnosing Malfunctioning Hydrocephalic Shunt Valves With a Flow Sensor

This study has been withdrawn prior to enrollment.
(Due to lack of enrollment.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00652249
First Posted: April 3, 2008
Last Update Posted: June 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Transonic Systems Inc.
March 31, 2008
April 3, 2008
June 5, 2012
March 2009
December 2010   (Final data collection date for primary outcome measure)
Volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage System as a function of the shunt valve pressure release setting and drainage bag position. [ Time Frame: 24 to 48 hours ]
Same as current
Complete list of historical versions of study NCT00652249 on ClinicalTrials.gov Archive Site
Recording of the pressure waveform related to the volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system. [ Time Frame: 24 to 48 hours ]
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Diagnosing Malfunctioning Hydrocephalic Shunt Valves With a Flow Sensor
A Flow Monitor for Pediatric Hydrocephalic Shunts - Study of Flow Sensor With the Shunt Valve

The study hypothesis is that a transit-time ultrasonic sensor can help doctors diagnose a malfunctioning shunt valve.

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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Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
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Non-Probability Sample
Pediatric hydrocephalus patients under the care of the Children's Hospital of Wisconsin, who have had an external ventriculostomy and are instrumented with an Extra-Ventricular Drainage system.
Hydrocephalus
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Extraventricular Drainage/Pressure
Includes pediatric hydrocephalus patients that are in recovery from shunt explanation.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2010
December 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosed with Hydrocephalus
  • Newborn through age 20
  • External Ventriculostomy with an Extra-Ventricular Drainage system installed

Exclusion Criteria:

  • Not diagnosed with Hydrocephalus
  • Older than age 20
  • No External Ventriculostomy with an Extra-Ventricular Drainage system installed
Sexes Eligible for Study: All
up to 20 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00652249
TSI-G-HYDRO-1B-H
2R44NS049680-02 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Transonic Systems Inc.
Transonic Systems Inc.
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Cornelis J Drost, BS, MS Transonic Systems Inc.
Study Director: Bruce A Kaufman, MD Children's Hospital and Health System Foundation, Wisconsin
Transonic Systems Inc.
June 2012