Diagnosing Malfunctioning Hydrocephalic Shunt Valves With a Flow Sensor

NCT00652249 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2012-06-05

No results posted yet for this study

Summary

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.

Conditions

  • Hydrocephalus

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH
  • Transonic Systems Inc.

    lead INDUSTRY

Principal Investigators

  • Cornelis J Drost, BS, MS · Transonic Systems Inc.

  • Bruce A Kaufman, MD · Children's Hospital and Health System Foundation, Wisconsin

Eligibility

Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00652249 on ClinicalTrials.gov