POCARED Diagnostics, LTD, Field Study Protocol

NCT ID: NCT01487148

Last Updated: 2011-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-06-30

Brief Summary

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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

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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.

Conditions

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Urinary Tract Infections

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pocared Diagnostics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonathan Gurfinkel

Role: STUDY_DIRECTOR

POCARED Diagnostics, Ltd.

Locations

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Southern California Permanente Medical Group (SCPMG) Regional Reference Laboratories

North Hollywood, California, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Riverside Methodist Hospital

Columbus, Ohio, United States

Site Status

Chaim Sheba Medical Center

Tel Aviv, , Israel

Site Status

Countries

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United States Israel

Central Contacts

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Jonathan Gurfinkel

Role: CONTACT

Phone: 972-8-6999779

Email: [email protected]

Other Identifiers

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POCARED001

Identifier Type: -

Identifier Source: org_study_id