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Clinical Evaluation of the APTIMA® Assay for Chlamydia Trachomatis Using the PANTHER™ System

NCT01358799 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2013-03-12

No results posted yet for this study

Summary

The objective of this multi-center clinical study is to demonstrate that the APTIMA(R) Assay for Chlamydia trachomatis (CT; "ACT Assay"), which is cleared for use on the TIGRIS DTS (Direct Transfer) System ("TIGRIS System"), can be tested on the PANTHER System. The intended use of the ACT Assay will be unchanged except for the inclusion of its use with the PANTHER System. ACT Assay performance on the PANTHER System is comparable to performance on the TIGRIS System.

Conditions

  • Chlamydia Trachomatis

Interventions

DEVICE

APTIMA Assay for Chlamydia trachomatis

APTIMA Assay for Chlamydia trachomatis

Sponsors & Collaborators

  • Gen-Probe, Incorporated

    lead INDUSTRY

Principal Investigators

  • Jennifer Reid, PhD · Gen-Probe, Incorporated

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01358799 on ClinicalTrials.gov