Ignite Creation Date:
2024-05-05 @ 10:42 PM
Last Modification Date:
2024-10-26 @ 10:22 AM
Study NCT ID:
NCT01167777
Status:
TERMINATED
Last Update Posted:
2015-11-26
First Post:
2010-07-21
Brief Title:
Multi-center Evaluation of the VERSANT CTGC DNA 10 Assay kPCRin Detecting C Trachomatis and N Gonorrhoeae
Sponsor:
Siemens Healthcare Diagnostics Inc
Organization:
Siemens Healthcare Diagnostics Inc
Study Overview
Official Title:
Multi-center Evaluation of the VERSANT CTGC DNA 10 Assay kPCRin Detecting C Trachomatis and N Gonorrhoeae
Status:
TERMINATED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Siemens Management decided not to release the product in the USA
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Multicenter clinical study to test a new qualitative in vitro nucleic acid amplification assay based on kPCR technology The assay is intended for the diagnosis of Chlamydia trachomatis CT and Neisseria gonorrhoeae GC
Detailed Description:
The study was terminated
This clinical trial protocol outlines the analytical and clinical performance characteristics that will be evaluated to demonstrate equivalency of the VERSANT CTGC DNA 10 kPCR Assay for product registration The Gen-Probe APTIMA Combo 2 Assay will be used as the CE-marked comparative method The studies conducted during the clinical trial are intended to provide data to support the safety and effectiveness as well as the labeling claims for the VERSANT CTGC Assay The study objectives are as follows
To demonstrate concordance with the Gen-Probe APTIMA Combo 2 Assay
To estimate the positive and negative predictive values for each specimen type included in the study
To estimate the indeterminate rate for each specimen type included in the study
To estimate the equivocal rate for each specimen type and
To assess reproducibility of the VERSANT CTCG DNA 10 Assay kPCR using the VERSANT kPCR Molecular System
Two 2 studies will be conducted to validate the analytical and clinical performance characteristics of the CTGC DNA 10 kPCR Assay Table 1 provides an overview of these studies
This clinical trial protocol outlines the analytical and clinical performance characteristics that will be evaluated to demonstrate equivalency of the VERSANT CTGC DNA 10 kPCR Assay for product registration The Gen-Probe APTIMA Combo 2 Assay will be used as the CE-marked comparative method The studies conducted during the clinical trial are intended to provide data to support the safety and effectiveness as well as the labeling claims for the VERSANT CTGC Assay The study objectives are as follows
To demonstrate concordance with the Gen-Probe APTIMA Combo 2 Assay
To estimate the positive and negative predictive values for each specimen type included in the study
To estimate the indeterminate rate for each specimen type included in the study
To estimate the equivocal rate for each specimen type and
To assess reproducibility of the VERSANT CTCG DNA 10 Assay kPCR using the VERSANT kPCR Molecular System
Two 2 studies will be conducted to validate the analytical and clinical performance characteristics of the CTGC DNA 10 kPCR Assay Table 1 provides an overview of these studies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None