Evaluation of the HSV 1 & 2 Assay in Specimens From Symptomatic Subjects
NCT ID: NCT02270099
Last Updated: 2017-08-14
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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COMPLETED
839 participants
OBSERVATIONAL
2014-12-31
2017-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Subjects with suspected HSV Lesions
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* The subject and/or legally authorized representative is willing and able to provide consent prior to study participation (a minor will need the documented consent of his/her parent or legal guardian, unless the site has an institutional review board-approved waiver for parental consent for minors)
Exclusion Criteria
* The subject used a topical or oral antiviral medication used to treat HSV within 21 days of enrollment
* Subject already participated in this study
* Subject has a history of illness that the principal investigator (PI) or designee considers could interfere with or affect the conduct, results, and/or completion of the study
* Subject has a history of illness that the PI or designee considers could create an unacceptable risk to the subject if enrolled in the study
ALL
No
Sponsors
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Hologic, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Rainer Ziermann
Role: STUDY_DIRECTOR
Hologic, Inc.
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Elite Clinical Studies, LLC
Phoenix, Arizona, United States
Sherif Khamis MD, Inc
Canoga Park, California, United States
Mills Clinical Research
Los Angeles, California, United States
Planned Parenthood of the Rocky Mountains
Denver, Colorado, United States
Yale School of Medicine
New Haven, Connecticut, United States
Perimeter Institute for Clinical Research, Inc. (PICR Clinic)
Atlanta, Georgia, United States
Advanced Clinical Research
Boise, Idaho, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
LSU Health Science Center
New Orleans, Louisiana, United States
LSU Health Science Center - Shreveport
Shreveport, Louisiana, United States
IRC Clinics
Towson, Maryland, United States
University of Mississippi Medical Center/Crossroads Clinic (MSDH)
Jackson, Mississippi, United States
Quality Clinical Research Inc.
Omaha, Nebraska, United States
Rochester Clinical Research, Inc.
Rochester, New York, United States
Laboratory Corporation of America
Burlington, North Carolina, United States
Westover Heights Clinic
Portland, Oregon, United States
Planned Parenthood of Southeastern Pennsylvania
Philadelphia, Pennsylvania, United States
Geneuity Clinical Research Services
Maryville, Tennessee, United States
Planned Parenthood Gulf Coast, Inc.
Houston, Texas, United States
Center for Clinical Studies
Webster, Texas, United States
American Regional University Pathologists
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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A10921-HSVPS-CSP-01
Identifier Type: -
Identifier Source: org_study_id
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