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Diagnosing Malfunctioning Hydrocephalic Shunt Valves With a Flow Sensor

T

Transonic Systems

Status

Withdrawn

Conditions

Hydrocephalus

Study type

Observational

Funder types

Industry
NIH

Identifiers

NCT00652249
2R44NS049680-02 (U.S. NIH Grant/Contract)
TSI-G-HYDRO-1B-H

Details and patient eligibility

About

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.

Sex

All

Ages

Under 20 years old

Volunteers

No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

Extraventricular Drainage/Pressure
Description:
Includes pediatric hydrocephalus patients that are in recovery from shunt explanation.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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