POCARED Diagnostics, LTD, Field Study Protocol | NCT01487148

Studies
POCARED Diagnostics, LTD, Field Study Protocol

NCT01487148

Sponsor

Pocared Diagnostics

Status

Unknown status

Last Update Posted

Dec 7, 2011Estimated

Enrollment

40,000Estimated

Phase

Not provided

Conditions

Urinary Tract Infections

Interventions

Not provided

Countries

United States
Israel

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

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Jun 2012Estimated

Completion Date

Jun 2012Estimated

First Submitted Date

Dec 2, 2011

First Submission Date that Met QC Criteria

Dec 6, 2011

First Posted Date

Dec 7, 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

Dec 6, 2011

Last Update Posted Date

Dec 7, 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

This study is designed to compare the performance of the P-1000 System, POCARED's Rapid Diagnostic System which uses optical fluorescence analysis, to standard methods of uropathogen quantification and identification.

Detailed Description

This study will be conducted at 5 sites, 4 in the United States and 1 site in Israel. 40,000 clinical specimens will be included and assessed by the laboratories using standard reference methods and the P-1000.

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

40,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Agreement	Agreement of the POCARED quantification and identification compared with standard methods.	6 months
Sensitivity	Sensitivity of the POCARED quantification and identification compared with standard methods.	6 months
Specificity	Specificity of the POCARED quantification and identification compared with standard methods.	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Samples arriving in the laboratory for urine culture

Exclusion Criteria:

Samples <=2mL
Specimens stored at room temperature for more than 2 hours (unless a preservative is used)
Specimens refrigerated for more than 24 hours
Specimens requesting low count urine culture (<100,000 CFU/mL [colony forming units per milliliter])
Bloody specimens

Accepts Healthy Volunteers

Yes

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

At least 70 consecutive leftover and de-identified urine samples arriving in the laboratory each day for culture will be tested.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jonathan Gurfinkel	Contact	972-8-6999779		jonathan.gurfinkel@pocared.com

Overall Officials

Name	Affiliation	Role
Jonathan Gurfinkel	POCARED Diagnostics, Ltd.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Southern California Permanente Medical Group (SCPMG) Regional Reference Laboratories		North Hollywood	California	91367	United States

Condition Browse Module

MeSH Terms

ID	Term
D014552	Urinary Tract Infections

Ancestor Terms

ID	Term
D007239	Infections
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided