Study of Shunt Flow Sensor Accuracy in Extra-ventricular... | NCT01108965

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

NCT01108965

Sponsor

Transonic Systems Inc.

Status

Completed

Last Update Posted

May 27, 2016Estimated

Enrollment

16Actual

Phase

Not provided

Conditions

Hydrocephalus
Nervous System Diseases
Infant, Newborn Diseases

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
5R44NS049680-03	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2010

Primary Completion Date

May 2012Actual

Completion Date

May 2012Actual

First Submitted Date

Apr 21, 2010

First Submission Date that Met QC Criteria

Apr 21, 2010

First Posted Date

Apr 22, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 25, 2016

Last Update Posted Date

May 27, 2016Estimated

Name	Class
National Institute of Neurological Disorders and Stroke (NINDS)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Extraventricular Drainage		Includes hydrocephalus patients that are in recovery from shunt explanation.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Recording of the pressure waveform related to the volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system.		24 hour period

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Hydrocephalus patients under the care of SUNY Upstate Medical University

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SUNY Upstate Medical University		Syracuse	New York	13210	United States

Condition Browse Module

MeSH Terms

ID	Term
D006849	Hydrocephalus
D009422	Nervous System Diseases
D007232	Infant, Newborn, Diseases

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided