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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This study has been withdrawn prior to enrollment.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.
  Purpose

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
Hydrocephalus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Flow Monitor for Pediatric Hydrocephalic Shunts - Study of Flow Sensor With the Shunt Valve

Resource links provided by NLM:


Further study details as provided by Transonic Systems Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: March 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Extraventricular Drainage/Pressure
Includes pediatric hydrocephalus patients that are in recovery from shunt explanation.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Transonic Systems Inc.
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Cornelis J Drost, BS, MS Transonic Systems Inc.
Study Director: Bruce A Kaufman, MD Children's Hospital and Health System Foundation, Wisconsin
  More Information

Responsible Party: Transonic Systems Inc.
ClinicalTrials.gov Identifier: NCT00652249     History of Changes
Other Study ID Numbers: TSI-G-HYDRO-1B-H
2R44NS049680-02 ( U.S. NIH Grant/Contract )
First Submitted: March 31, 2008
First Posted: April 3, 2008
Last Update Posted: June 5, 2012
Last Verified: June 2012

Keywords provided by Transonic Systems Inc.:
Hydrocephalus
shunt dysfunction
shunt flow

Additional relevant MeSH terms:
Hydrocephalus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases