Evaluation of the Atlas Genetics io® CTNG System

Completed

• Conditions: Chlamydia Trachomatis; Gonorrhea

• Registration Number: NCT03071510
• Lead Sponsor: Binx Health Limited

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-02-27
• Study First Submitted QC: 2017-03-01
• Study First Posted: 2017-03-07
• Study Start: 2017-05-18
• Primary Completion: 2019-08-30
• Study Completion: 2019-08-30
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-02
• Last Update Posted: 2020-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7128

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic Accuracy compared to positive Composite Infected Status from comparator devices	Up to 7 days	The assessment of the diagnostic accuracy of the study device as compared to positive Composite Infected Status from comparator devices

Trial Locations

Locations (10)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Wake Forest Center for Reproductive Medicine; 🇺🇸 Greensboro, North Carolina, United States

Planned Parenthood Gulf Coast; 🇺🇸 Houston, Texas, United States

Planned Parenthood Southeastern Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Mississippi; 🇺🇸 Jackson, Mississippi, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

Louisiana State University; 🇺🇸 New Orleans, Louisiana, United States

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

AIDS Healthcare Foundation; 🇺🇸 Los Angeles, California, United States