Evaluation of the Atlas Genetics io® CTNG System



Status:Recruiting
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:14 - Any
Updated:10/13/2018
Start Date:May 18, 2017
End Date:June 30, 2019
Contact:John Hladkiwskyj, B.Sc.
Email:john.hladkiwskyj@mybinxhealth.com
Phone:+44 1225 717932

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Trial Summary
Trial Overview
Inclusion Criteria

IO-CTNG: A Multi-Centre Evaluation of the Atlas Genetics io® CTNG System Used in Centralised and Point of Care Settings

Atlas Genetics io® system results are compared with those obtained from comparator devices.

Results from the Atlas Genetics io® system are compared with a Composite Infection Status
obtained from testing on three commonly used comparator devices.

This is a prospective, single-arm, multi-centre investigation enrolling up to 12,000 adult
participants over 14 years of age who are undergoing testing for the presence of CT/NG.

Inclusion Criteria:

1. Symptomatic and asymptomatic individuals ≥14 years of age

Exclusion Criteria:

1. Treatment with antibiotics known to be effective against Chlamydia trachomatis and/or
Neisseria gonorrhoeae within the previous 4 weeks before inclusion in the study.

2. Unable to self-obtain a vaginal swab or urine sample of at least 30 mL
We found this trial at
10
sites
Indiana University
425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: Aaron Ermel, MD
Phone: 317-274-3248
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Johns Hopkins University
3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Principal Investigator: Charlotte Gaydos, DrPH
Phone: 410-614-0932
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Baltimore, MD
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Marcia Hobbs, PhD
Phone: 919-966-5050
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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University of Alabama
Birmingham, Alabama 35294
Principal Investigator: Barbara Van der Pol, PhD
Phone: 205-975-4268
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Birmingham, AL
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Wake Forest Center for Reproductive Medicine
3903 North Elm Street
Greensboro, North Carolina 27455
Principal Investigator: Candice McNeil, MD, MPH
Phone: 336-716-2700
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Greensboro, NC
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Planned Parenthood Gulf Coast
Houston, Texas 77023
Principal Investigator: LaShonda Crane, FNP
Phone: 713-831-6561
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Houston, TX
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University of Mississippi
Jackson, Mississippi 39216
Principal Investigator: Leandro Mena, MD
Phone: 601-984-1653
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Jackson, MS
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AIDS Healthcare Foundation
Los Angeles, California 90028
Principal Investigator: Adam C Cohen, PhD, MPH
Phone: 323-436-8900
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Los Angeles, CA
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Louisiana State University
New Orleans, Louisiana 70112
Principal Investigator: Stephanie Taylor, MD
Phone: 504-568-5031
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New Orleans, LA
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Planned Parenthood Southeastern Pennsylvania
Philadelphia, Pennsylvania 19107
Principal Investigator: Joel Lebed, DO
Phone: 215-351-5543
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Philadelphia, PA
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