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

May 25, 2016 updated by: Transonic Systems Inc.

A Flow Monitor for Pediatric Hydrocephalic Shunts

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hydrocephalus patients under the care of SUNY Upstate Medical University

Description

Inclusion Criteria:

  • Diagnosed with hydrocephalus
  • Instrumented with an Extraventricular drainage system

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Extraventricular Drainage
Includes hydrocephalus patients that are in recovery from shunt explanation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system.
Time Frame: 24 hour-period
24 hour-period

Secondary Outcome Measures

Outcome Measure
Time Frame
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
24 hour period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Transonic Systems Inc.

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

  • Principal Investigator: Cornelis J Drost, Transonic Systems Inc.
  • Principal Investigator: Satish Krishnamurthy, MD, State University of New York - Upstate Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (ACTUAL)

May 1, 2012

Study Completion (ACTUAL)

May 1, 2012

Study Registration Dates

First Submitted

April 21, 2010

First Submitted That Met QC Criteria

April 21, 2010

First Posted (ESTIMATE)

April 22, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

May 27, 2016

Last Update Submitted That Met QC Criteria

May 25, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TSI-C-HYDRO-2A-H
  • 5R44NS049680-03 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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