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NCT00652249 Clinical Trial

Diagnosing Malfunctioning Hydrocephalic Shunt Valves With a Flow Sensor

Hydrocephalus Clinical Trial

Official title:
A Flow Monitor for Pediatric Hydrocephalic Shunts - Study of Flow Sensor With the Shunt Valve

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00652249
Other study ID # TSI-G-HYDRO-1B-H
Secondary ID 2R44NS049680-02
Status Withdrawn
Phase N/A
First received March 31, 2008
Last updated June 4, 2012
Start date March 2009
Est. completion date December 2010

Study information
Verified date June 2012
Source Transonic Systems Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group N/A to 20 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
United States Children's Hospital of Wisconsin Milwaukee Wisconsin

Sponsors (2)
Lead Sponsor Collaborator
Transonic Systems Inc. National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 24 to 48 hours No
Secondary Recording of the pressure waveform related to the volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system. 24 to 48 hours No
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Completed NCT02381977 - Prevalence of Acute Critical Neurological Disease in Children: a Global Epidemiological Assessment N/A
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