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Evaluation of the Atlas Genetics io® CTNG System (IO-CTNG)

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ClinicalTrials.gov Identifier: NCT03071510
Recruitment Status : Recruiting
First Posted : March 7, 2017
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Atlas Genetics Limited

Brief Summary:
The objective of the study is to compare Atlas Genetics io® system results with those obtained from comparator devices.

Condition or disease Intervention/treatment
Chlamydia Trachomatis Gonorrhea Device: Atlas Genetics io® system

Study Type : Observational
Estimated Enrollment : 12000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: IO-CTNG: A Multi-Centre Evaluation of the Atlas Genetics io® CTNG System Used in Centralised and Point of Care Settings
Actual Study Start Date : May 18, 2017
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : June 30, 2019

Intervention Details:
  • Device: Atlas Genetics io® system
    Specimen Collection


Primary Outcome Measures :
  1. Diagnostic Accuracy compared to positive Composite Infected Status from comparator devices [ Time Frame: Up to 7 days ]
    The assessment of the diagnostic accuracy of the study device as compared to positive Composite Infected Status from comparator devices



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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Participants over 14 years of age for whom testing for Chlamydia trachomatis and/or Neisseria gonorrhoeae is appropriate
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03071510


Contacts
Contact: John Hladkiwskyj, B.Sc. +44 1225 717932 john.hladkiwskyj@atlasgenetics.com
Contact: David Pearce, PhD +44 1225 717932 david.pearce@atlasgenetics.com

Locations
United States, Alabama
University of Alabama Recruiting
Birmingham, Alabama, United States, 35294
Contact: Barbara Van der Pol, PhD    205-975-4268    bvanderpol@uabmc.edu   
Principal Investigator: Barbara Van der Pol, PhD         
United States, California
AIDS Healthcare Foundation Recruiting
Los Angeles, California, United States, 90046
Contact: Mark McGrath, MPH    323-436-8900      
Principal Investigator: Mark McGrath, MPH         
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: James Williams    317-274-3248    jaawilli@iu.edu   
Principal Investigator: Kenneth Fife, MD         
United States, Louisiana
Louisiana State University Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Stephanie Taylor, MD    504-568-5031    STaylo2@lsuhsc.edu   
Principal Investigator: Stephanie Taylor, MD         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Contact: Charlotte Gaydos, DrPH    410-614-0932    cgaydos@jhmi.edu   
Principal Investigator: Charlotte Gaydos, DrPH         
United States, Mississippi
University of Mississippi Recruiting
Jackson, Mississippi, United States, 39216
Contact: Melverta M Bender, PhD    601-984-1653    mbender@umc.edu   
Principal Investigator: Leandro Mena, MD         
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Marcia Hobbs, PhD    919-966-5050    marcia_hobbs@med.unc.edu   
Principal Investigator: Marcia Hobbs, PhD         
Wake Forest Center for Reproductive Medicine Recruiting
Greensboro, North Carolina, United States, 27455
Contact: Andrea Lewis    336-716-2700    aalewis@wakehealth.edu   
Principal Investigator: Laura H Bachmann, MD, MPH         
United States, Pennsylvania
Planned Parenthood Southeastern Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Sonja V Ross, PhD    215-351-5543    Sonja.Ross@ppsp.org   
Principal Investigator: Joel Lebed, DO         
United States, Texas
Planned Parenthood Gulf Coast Recruiting
Houston, Texas, United States, 77023
Contact: Melissa Farrell, RN    713-831-6561    Melissa.farrell@ppgulfcoast.org   
Principal Investigator: LaShonda Crane, FNP         
Sponsors and Collaborators
Atlas Genetics Limited

Responsible Party: Atlas Genetics Limited
ClinicalTrials.gov Identifier: NCT03071510     History of Changes
Other Study ID Numbers: MOB-VTP-001
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Gonorrhea
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female