Study to Test the Accuracy of a Prototype Handheld PT/INR... | NCT01349712

Studies
Study to Test the Accuracy of a Prototype Handheld PT/INR Device

NCT01349712

Sponsor

Universal Biosensors Pty Ltd

Status

Unknown status

Last Update Posted

May 9, 2011Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Blood Coagulation Disorders

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Nov 2011Estimated

Completion Date

Nov 2011Estimated

First Submitted Date

Apr 29, 2011

First Submission Date that Met QC Criteria

May 5, 2011

First Posted Date

May 9, 2011Estimated

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 5, 2011

Last Update Posted Date

May 9, 2011Estimated

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 purpose of this study is to measure prothrombin time (PT) on an experimental device and a commercially available device on persons receiving coumadin (warfarin)treatment.

Detailed Description

This study will require participants to have up to 2 finger-punctures taken and sample tested on a strip and meter system for both the experimental and commercially available devices.

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

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Coumadin (warfarin)		Subjects are required to be currently receiving coumadin (warfarin) treatment.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PT/INR values from the experimental device will be statistically correlated to results obtained from a commercially available device	To determine the correlation of PT/INR values between an experimental and commercial device.	Fives days to collect data and up to two weeks to generate correlation graph

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Currently taking coumadin (warfarin)
Aged 18 years or older
Able and willing to provide informed consent
Can understand (read and write) English

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects currently receving coumadin(warfarin) treatment

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Richard Ward, Pharm D	Harding University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
White River Diagnostic Clinic		Batesville	Arkansas	72501	United States

Type	Date	Date Unknown
Release	Sep 6, 2011
Reset	Oct 12, 2011
Release	Jun 12, 2012
Reset	Jul 12, 2012
Release	Jun 17, 2013
Reset	Sep 1, 2013

Submission Tracking

Estimated Results First Submitted Date

Sep 6, 2011

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Sep 6, 2011			Oct 12, 2011
Jun 12, 2012

Condition Browse Module

MeSH Terms

ID	Term
D001778	Blood Coagulation Disorders

Ancestor Terms

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided