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NCT03071510 Clinical Trial

Evaluation of the Atlas Genetics io® CTNG System

Gonorrhea Clinical Trial

— IO-CTNG  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03071510
Other study ID # MOB-VTP-001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 18, 2017
Est. completion date August 30, 2019

Study information
Verified date April 2020
Source Binx Health Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 7128
Est. completion date August 30, 2019
Est. primary completion date August 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Atlas Genetics io® system
Specimen Collection

Locations
Country Name City State
United States Johns Hopkins University Baltimore Maryland
United States University of Alabama Birmingham Alabama
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina
United States Wake Forest Center for Reproductive Medicine Greensboro North Carolina
United States Planned Parenthood Gulf Coast Houston Texas
United States Indiana University Indianapolis Indiana
United States University of Mississippi Jackson Mississippi
United States AIDS Healthcare Foundation Los Angeles California
United States Louisiana State University New Orleans Louisiana
United States Planned Parenthood Southeastern Pennsylvania Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Binx Health Limited

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnostic Accuracy compared to positive Composite Infected Status from comparator devices The assessment of the diagnostic accuracy of the study device as compared to positive Composite Infected Status from comparator devices Up to 7 days
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