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Completed

NCT Number: NCT01108965

Study of Shunt Flow Sensor Accuracy in Extra-ventricular Drains.

The study hypothesis is that an ultrasonic flow sensor can accurately measure flow in hydrocephalic shunts.

The ultrasonic sensor will measure cerebrospinal fluid drainage in hydrocephalus patients with external ventriculostomies and extra-ventricular drainage systems. The sensor measurements will be compared with the volume of fluid collected by the drainage bag.

After a 24-hour measurement period, the doctor will change the drainage bag position to simulate the patient sitting up and leaning back, to see if this temporarily stops flow through the drainage line.

This data will show whether the sensor accurately measures typical drainage flows seen in hydrocephalus patients. This research will help develop an implantable flow monitor for pediatric hydrocephalus patients.

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Key information

Conditions

Hydrocephalus Brain Diseases Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn Diseases Infant, Newborn, Diseases Nervous System Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with hydrocephalus
  • Instrumented with an Extraventricular drainage system

Exclusion criteria

  • Not diagnosed with hydrocephalus
  • Not instrumented with an extraventricular drainage system

Treatment and study plan

Primary outcomes

  1. Volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system.

    Time frame: 24 hour-period

Secondary outcomes

  1. Recording of the pressure waveform related to the volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system.

    Time frame: 24 hour period

Sponsors and collaborators

Lead sponsor

Transonic Systems Inc.

Industry

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

A Flow Monitor for Pediatric Hydrocephalic Shunts

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Apr 22, 2010
Registry last updated
May 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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