Status:
COMPLETED
Clinical Evaluation of the Click Sexual Health Test for the Detection of Neisseria Gonorrhoeae (NG), Trichomonas Vaginalis (TV), and Chlamydia Trachomatis (CT) in Women
Lead Sponsor:
Visby Medical
Conditions:
Chlamydial Infection
Gonococcal Infection
Eligibility:
FEMALE
14-99 years
Brief Summary
This study is a multi-center study with a minimum of three CLIA-waived intended operator sites in the United States in which prospectively self-collected vaginal specimens obtained from subjects who a...
Eligibility Criteria
Inclusion
- Willing and able to give voluntary written informed consent and assent form (or the parental/legal guardian will provide parental permission) before any study-related procedure is performed.
- Female at birth. (Pregnant and breastfeeding women are eligible).
- Age greater than or equal to 14 years at the time of enrollment
- Able to read and understand the procedural information provided for the study.
- Able and willing to follow all study procedures, including performing self-collection of one vaginal swab and permitting a HCP to collect three additional vaginal swabs.
Exclusion
- Have a medical condition, serious intercurrent illness, or other circumstance that, in the Investigator's judgement, could jeopardize the subjects's safety, or could interfere with study procedures.
- Enrollment in the DMID 18-0024 and this study previously.
- Use of antiperspirants and deodorants or the following vaginal products: douches, washes, lubricants, vaginal wipes, vaginal moisturizers, or feminine hygiene spray in the genital area, within 48 hours prior to enrollment.
Key Trial Info
Start Date :
September 16 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 3 2019
Estimated Enrollment :
309 Patients enrolled
Trial Details
Trial ID
NCT04098900
Start Date
September 16 2019
End Date
December 3 2019
Last Update
February 17 2020
Active Locations (5)
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1
Therafirst Medical Center
Fort Lauderdale, Florida, United States, 33308
2
Planned Parenthood North Central States
Saint Paul, Minnesota, United States, 55114
3
Planned Parenthood of the St. Louis Region and Southwest Missouri
St Louis, Missouri, United States, 63108
4
Lawrence OB/GYN Clinical Research, LLC
Lawrenceville, New Jersey, United States, 08648