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

Nervous System Diseases Clinical Trial

Official title:

A Flow Monitor for Pediatric Hydrocephalic Shunts

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01108965
• Other study ID #: TSI-C-HYDRO-2A-H
• Secondary ID: 5R44NS049680-03
• Status: Completed
• Phase: N/A
• First received: April 21, 2010
• Last updated: May 25, 2016
• Start date: August 2010
• Est. completion date: May 2012

Study information

• Verified date: May 2016
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Hydrocephalus
• Infant, Newborn Diseases
• Nervous System Diseases

Locations

Country	Name	City	State
United States	SUNY Upstate Medical University	Syracuse	New York

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.		24 hour-period	No
Secondary	Recording of the pressure waveform related to the volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system.		24 hour period	No