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OpenTrials
Completed

NCT Number: NCT03071510

Evaluation of the Atlas Genetics io® CTNG System

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

Completed

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Key information

Conditions

Chlamydia Trachomatis Bacterial Infections Bacterial Infections and Mycoses Communicable Diseases Genital Diseases Gonorrhea Gram-Negative Bacterial Infections Infections Neisseriaceae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Bacterial Urogenital Diseases

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Symptomatic and asymptomatic individuals ≥14 years of age

Exclusion criteria

  • Treatment with antibiotics known to be effective against Chlamydia trachomatis and/or Neisseria gonorrhoeae within the previous 4 weeks before inclusion in the study.
  • Unable to self-obtain a vaginal swab or urine sample of at least 30 mL

Treatment and study plan

Atlas Genetics io® system

Device

Specimen Collection

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Binx Health Limited

Industry

Registry information

Official study title

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

Acronym: IO-CTNG

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 7, 2017
Registry last updated
Apr 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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