TerminatedNot Applicable

Multi-center Evaluation of the VERSANT® CT/GC DNA 1.0 Assay (kPCR)in Detecting C. Trachomatis and N. Gonorrhoeae

Stopped: Siemens Management decided not to release the product in the USA.

United States2,296 participantsStarted 2010-08

Plain-language 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).

Who can participate

Age range18 Years – 99 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subject is 18 years of age or older. * Subject signed an IRB approved informed consent form. * Subject is able to follow verbal and written instructions. Exclusion Criteria: * Subject has been on antibiotic therapy within 21 days prior to study enrollment. * Subject urinated within one hour prior to sample collection.

What they're measuring

Prevalence of CT and/or GC disease by clinical site

Timeframe: Study terminated

Trial details

NCT IDNCT01167777

SponsorSiemens Healthcare Diagnostics Inc

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2010-12

View on ClinicalTrials.gov More Chlamydia trials