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

A Flow Monitor for Pediatric Hydrocephalic Shunts

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01108965
Enrollment
16
Registered
2010-04-22
Start date
2010-08-31
Completion date
2012-05-31
Last updated
2016-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hydrocephalus, Infant, Newborn Diseases, Nervous System Diseases

Keywords

Hydrocephalus, Shunt Dysfunction, Shunt Flow

Brief 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.

Interventions

None listed

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)
CollaboratorNIH
Transonic Systems Inc.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Diagnosed with hydrocephalus * Instrumented with an Extraventricular drainage system

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system.24 hour-period

Secondary

MeasureTime frame
Recording of the pressure waveform related to the volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system.24 hour period

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026