Clinical Evaluation of the Aptima® Combo 2® Assay Using the Panther® System in Female Urine Samples
NCT ID: NCT02795975
Last Updated: 2017-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
1766 participants
OBSERVATIONAL
2016-06-30
2017-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Eligibility Criteria
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Inclusion Criteria
* 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 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.
14 Years
FEMALE
Yes
Sponsors
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Hologic, Inc.
INDUSTRY
Responsible Party
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Locations
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The University of Alabama at Birmingham
Birmingham, Alabama, United States
Planned Parenthood of Southern New England, Inc
New Haven, Connecticut, United States
Segal Institute for Clinical Research
Miami, Florida, United States
Eskenazi Hospital - Indiana University School of Medicine
Indianapolis, Indiana, United States
Clinical Trials Management, LLC
Mandeville, Louisiana, United States
Beyer Research
Kalamazoo, Michigan, United States
Quality Clinical Research, Inc.
Omaha, Nebraska, 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
Multnomah County Health Department, STD Clinic
Portland, Oregon, United States
Geneuity
Maryville, Tennessee, United States
Planned Parenthood Gulf Coast, Inc.
Houston, Texas, United States
Brownstone Clinical Trials
Irving, Texas, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Tidewater Clinical Research, Inc.
Virginia Beach, Virginia, United States
University of Washington Center for AIDS & STD
Seattle, Washington, United States
Countries
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Other Identifiers
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A10417-AC2PS-CSP-02
Identifier Type: -
Identifier Source: org_study_id
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