POCARED Diagnostics, LTD, Field Study Protocol
Recruitment status was Not yet recruiting
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.
Urinary Tract Infections
|Study Design:||Time Perspective: Prospective|
|Official Title:||POCARED Diagnostics, LTD, Field Study Protocol|
- Agreement [ Time Frame: 6 months ] [ Designated as safety issue: No ]Agreement of the POCARED quantification and identification compared with standard methods.
- Sensitivity [ Time Frame: 6 months ] [ Designated as safety issue: No ]Sensitivity of the POCARED quantification and identification compared with standard methods.
- Specificity [ Time Frame: 6 months ] [ Designated as safety issue: No ]Specificity of the POCARED quantification and identification compared with standard methods.
Biospecimen Retention: None Retained
Samples are de-identified leftover samples.
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||June 2012|
|Estimated Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01487148
|Contact: Jonathan Gurfinkelfirstname.lastname@example.org|
|United States, California|
|Southern California Permanente Medical Group (SCPMG) Regional Reference Laboratories||Not yet recruiting|
|North Hollywood, California, United States, 91367|
|Principal Investigator: Beth M. Marlowe, Ph.D.|
|United States, Minnesota|
|Mayo Clinic||Not yet recruiting|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator: Robin Patel, M.D.|
|United States, Ohio|
|Cleveland Clinic||Not yet recruiting|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator: Gerri S. Hall, Ph.D|
|Riverside Methodist Hospital||Not yet recruiting|
|Columbus, Ohio, United States, 43214|
|Principal Investigator: Sue Fuhrman, M.D.|
|Chaim Sheba Medical Center||Not yet recruiting|
|Tel Aviv, Israel|
|Principal Investigator: Gill Smollan, M.D.|
|Study Director:||Jonathan Gurfinkel||POCARED Diagnostics, Ltd.|