Diagnosing Malfunctioning Hydrocephalic Shunt Valves With a Flow Sensor

This study has been withdrawn prior to enrollment.
(Due to lack of enrollment.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Transonic Systems Inc.
ClinicalTrials.gov Identifier:
NCT00652249
First received: March 31, 2008
Last updated: June 4, 2012
Last verified: June 2012
  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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   up to 20 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00652249

Locations
United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Transonic Systems Inc.
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

No publications provided

Responsible Party: Transonic Systems Inc.
ClinicalTrials.gov Identifier: NCT00652249     History of Changes
Other Study ID Numbers: TSI-G-HYDRO-1B-H, 2R44NS049680-02
Study First Received: March 31, 2008
Last Updated: June 4, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 23, 2014