Clinical Study of a Diagnostic Device for NG, TV and CT in Women
Public ClinicalTrials.gov record NCT03852316. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Pivotal Study of a Single-Use, Point-of-Care Molecular Diagnostic Device for the Detection of Neisseria Gonorrhoeae (NG), Trichomonas Vaginalis (TV), and Chlamydia Trachomatis (CT) in Women
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a multi-center study with a minimum of three sites in the United States. The study will enroll approximately 1750 female subjects, 14 years of age and older, and will have a study duration of approximately 9 months after enrollment of the first subject. Female subjects seen at the participating sites for any reason will be evaluated for enrollment in this study. All subjects will be managed per standard of care as applicable. Subjects who are enrolled in the study will perform self-collection of a vaginal swab to be tested by Click device and allow the health care provider (HCP) to collect three additional vaginal swabs to be tested by recognized FDA-cleared comparator methods. Subjects will complete the study in a single visit. The primary objective is to assess the performance of the Click device for detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) in self-collected vaginal specimens as compared to Patient Infected Status (PIS) determined by three approved comparator assays using vaginal specimens collected by a qualified HCP in support of obtaining FDA clearance. and a Clinical Laboratory Improvement Amendments (CLIA) Waiver.
Study identification
- NCT ID
- NCT03852316
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 1,585 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 14 Years to 99 Years
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 26, 2019
- Primary completion
- Dec 1, 2019
- Completion
- Dec 1, 2019
- Last update posted
- Jan 12, 2022
2019
United States locations
- U.S. sites
- 10
- U.S. states
- 7
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Axis Clinical Trials | Los Angeles | California | 90036 | — |
| University of California, San Diego - Antiviral Research Center | San Diego | California | 92103-8208 | — |
| San Francisco Department of Public Health - San Francisco City Clinic | San Francisco | California | 94103-4030 | — |
| South Florida Clinical Trials | Hialeah | Florida | 33016 | — |
| Florida International University - Student Health Center | Miami | Florida | 33199 | — |
| Cook County Health and Hospitals System - Ruth M Rothstein CORE Center | Chicago | Illinois | 60612 | — |
| Johns Hopkins Hospital - Medicine - Infectious Diseases | Baltimore | Maryland | 21205 | — |
| University of Mississippi - Infectious Diseases | Jackson | Mississippi | 39202 | — |
| Impact Clinical Trials | Las Vegas | Nevada | 89106 | — |
| Philadelphia Department of Public Health - Health Center 1 | Philadelphia | Pennsylvania | 19145 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03852316, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 12, 2022 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03852316 live on ClinicalTrials.gov.