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

April 2, 2020 updated by: Binx Health Limited

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

7128

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama
    • California
      • Los Angeles, California, United States, 90046
        • AIDS Healthcare Foundation
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Louisiana State University
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill
      • Greensboro, North Carolina, United States, 27455
        • Wake Forest Center for Reproductive Medicine
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Planned Parenthood Southeastern Pennsylvania
    • Texas
      • Houston, Texas, United States, 77023
        • Planned Parenthood Gulf Coast

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants over 14 years of age for whom testing for Chlamydia trachomatis and/or Neisseria gonorrhoeae is appropriate

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Binx Health Limited

Investigators

  • Principal Investigator: Barbara Van Der Pol, PhD, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 18, 2017

Primary Completion (Actual)

August 30, 2019

Study Completion (Actual)

August 30, 2019

Study Registration Dates

First Submitted

February 27, 2017

First Submitted That Met QC Criteria

March 1, 2017

First Posted (Actual)

March 7, 2017

Study Record Updates

Last Update Posted (Actual)

April 3, 2020

Last Update Submitted That Met QC Criteria

April 2, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOB-VTP-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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