Diagnosing Malfunctioning Hydrocephalic Shunt Valves With a Flow Sensor
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|ClinicalTrials.gov Identifier: NCT00652249|
Recruitment Status : Withdrawn (Due to lack of enrollment.)
First Posted : April 3, 2008
Last Update Posted : June 5, 2012
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||A Flow Monitor for Pediatric Hydrocephalic Shunts - Study of Flow Sensor With the Shunt Valve|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
Includes pediatric hydrocephalus patients that are in recovery from shunt explanation.
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00652249
|United States, Wisconsin|
|Children's Hospital of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||Cornelis J Drost, BS, MS||Transonic Systems Inc.|
|Study Director:||Bruce A Kaufman, MD||Children's Hospital and Health System Foundation, Wisconsin|