Diagnosing Malfunctioning Hydrocephalic Shunt Valves With a Flow Sensor
|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Recruitment Status : Withdrawn (Due to lack of enrollment.)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 ]
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|