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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02795975
Other study ID # A10417-AC2PS-CSP-02
Secondary ID
Status Terminated
Phase N/A
First received June 2, 2016
Last updated March 22, 2017
Start date June 30, 2016
Est. completion date March 1, 2017

Study information

Verified date March 2017
Source Hologic, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The objective of this study is to evaluate the performance characteristics of the AC2 assay on the Panther system using female urine specimens.


Recruitment information / eligibility

Status Terminated
Enrollment 1766
Est. completion date March 1, 2017
Est. primary completion date March 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 14 Years and older
Eligibility Inclusion Criteria:

- The subject is =14 years of age at the time of enrollment and is currently sexually active (eg, has had penile/vaginal intercourse within the past 6 months).

- For subjects under 18 years old, assent of the subject and/or parental/legal guardian permission has been obtained if required by the institutional review board (IRB).

- The subject and/or legally authorized representative is willing and able to undergo the informed consent process prior to study participation, and:

- reports symptoms consistent with a suspected STI (eg, abnormal discharge, genital itching, pain/discomfort during sexual intercourse or urination, and/or lower abdominal discomfort); or

- is asymptomatic and known to be partners with, or a contact of, a person with a confirmed or suspected STI; or

- is asymptomatic and undergoing screening evaluation for possible STIs; or

- is asymptomatic and undergoing a routine pelvic examination.

Exclusion Criteria:

- The subject took antibiotic medications within the last 21 days prior to collection.

- The subject already participated in the study.

- The subject has a history of illness that the PI or designee considers could interfere with or affect the conduct, results, and/or completion of the study.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States The University of Alabama at Birmingham Birmingham Alabama
United States LabCorp Burlington North Carolina
United States University of Cincinnati Cincinnati Ohio
United States University Hospitals Case Medical Center Cleveland Ohio
United States The Ohio State University Columbus Ohio
United States Planned Parenthood Gulf Coast, Inc. Houston Texas
United States Eskenazi Hospital - Indiana University School of Medicine Indianapolis Indiana
United States Brownstone Clinical Trials Irving Texas
United States Beyer Research Kalamazoo Michigan
United States Clinical Trials Management, LLC Mandeville Louisiana
United States Geneuity Maryville Tennessee
United States Segal Institute for Clinical Research Miami Florida
United States Planned Parenthood of Southern New England, Inc New Haven Connecticut
United States Quality Clinical Research, Inc. Omaha Nebraska
United States Multnomah County Health Department, STD Clinic Portland Oregon
United States Clinical Trials of Texas, Inc. San Antonio Texas
United States University of Washington Center for AIDS & STD Seattle Washington
United States Tidewater Clinical Research, Inc. Virginia Beach Virginia

Sponsors (1)

Lead Sponsor Collaborator
Hologic, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sensitivity and specificity Enrollment ongoing until estimated March 2017
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