Evaluation of the Atlas Genetics io® CTNG System
IO-CTNG
IO-CTNG: A Multi-Centre Evaluation of the Atlas Genetics io® CTNG System Used in Centralised and Point of Care Settings
1 other identifier
observational
7,128
1 country
10
Brief Summary
Atlas Genetics io® system results are compared with those obtained from comparator devices.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2017
Typical duration for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2017
CompletedFirst Posted
Study publicly available on registry
March 7, 2017
CompletedStudy Start
First participant enrolled
May 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2019
CompletedApril 3, 2020
April 1, 2020
2.3 years
February 27, 2017
April 2, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Interventions
Specimen Collection
Eligibility Criteria
Participants over 14 years of age for whom testing for Chlamydia trachomatis and/or Neisseria gonorrhoeae is appropriate
You may qualify if:
- \. Symptomatic and asymptomatic individuals ≥14 years of age
You may not qualify if:
- Unable to self-obtain a vaginal swab or urine sample of at least 30 mL
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
University of Alabama
Birmingham, Alabama, 35294, United States
AIDS Healthcare Foundation
Los Angeles, California, 90046, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Louisiana State University
New Orleans, Louisiana, 70112, United States
Johns Hopkins University
Baltimore, Maryland, 21205, United States
University of Mississippi
Jackson, Mississippi, 39216, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Wake Forest Center for Reproductive Medicine
Greensboro, North Carolina, 27455, United States
Planned Parenthood Southeastern Pennsylvania
Philadelphia, Pennsylvania, 19107, United States
Planned Parenthood Gulf Coast
Houston, Texas, 77023, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barbara Van der Pol, PhD
University of Alabama at Birmingham
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2017
First Posted
March 7, 2017
Study Start
May 18, 2017
Primary Completion
August 30, 2019
Study Completion
August 30, 2019
Last Updated
April 3, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share