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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Transonic Systems Inc.
ClinicalTrials.gov Identifier:
NCT01108965
First received: April 21, 2010
Last updated: May 30, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition
Hydrocephalus
Nervous System Diseases
Infant, Newborn Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Flow Monitor for Pediatric Hydrocephalic Shunts

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Transonic Systems Inc.:

Primary Outcome Measures:
  • Volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system. [ Time Frame: 24 hour-period ] [ 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 hour period ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Cerebrospinal fluid samples are to be retained


Estimated Enrollment: 15
Study Start Date: August 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Extraventricular Drainage
Includes hydrocephalus patients that are in recovery from shunt explanation.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hydrocephalus patients under the care of SUNY Upstate Medical University

Criteria

Inclusion Criteria:

  • Diagnosed with hydrocephalus
  • Instrumented with an Extraventricular drainage system

Exclusion Criteria:

  • Not diagnosed with hydrocephalus
  • Not instrumented with an extraventricular drainage system
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01108965

Locations
United States, New York
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Sponsors and Collaborators
Transonic Systems Inc.
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
  More Information

No publications provided

Responsible Party: Transonic Systems Inc.
ClinicalTrials.gov Identifier: NCT01108965     History of Changes
Other Study ID Numbers: TSI-C-HYDRO-2A-H, 5R44NS049680-03
Study First Received: April 21, 2010
Last Updated: May 30, 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
Nervous System Diseases
Brain Diseases
Central Nervous System Diseases
Intracranial Hypertension

ClinicalTrials.gov processed this record on May 16, 2013