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Clinical Study of a Diagnostic Device for NG, TV and CT in Women
NCT03852316 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DEVICE Click Device
Study Locations (10)
California
- Axis Clinical Trials — Los Angeles
- University of California, San Diego - Antiviral Research Center — San Diego
- San Francisco Department of Public Health - San Francisco City Clinic — San Francisco
Florida
- South Florida Clinical Trials — Hialeah
- Florida International University - Student Health Center — Miami
Illinois
- Cook County Health and Hospitals System - Ruth M Rothstein CORE Center — Chicago
Maryland
- Johns Hopkins Hospital - Medicine - Infectious Diseases — Baltimore
Mississippi
- University of Mississippi - Infectious Diseases — Jackson
Nevada
- Impact Clinical Trials — Las Vegas
Pennsylvania
- Philadelphia Department of Public Health - Health Center 1 — Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,585 participants |
| Start Date | 2019-02-27 |
| Est. Completion | 2019-12-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03852316
The ClinicalTrials.gov registry entry for NCT03852316 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,585 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Chlamydial Infection appearing as the primary indexed condition, and to 1 intervention — of which Click Device is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03852316 reports 10 study locations spanning 7 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03852316 about?
NCT03852316 is a clinical study titled "Clinical Study of a Diagnostic Device for NG, TV and CT in Women". 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 participat...
What is the current status of trial NCT03852316?
This trial is currently completed. It is a NA study. The enrollment target is 1,585 participants. The study started on 2019-02-27. Estimated completion is 2019-12-02.
What conditions does trial NCT03852316 study?
This clinical trial studies the following conditions: Chlamydial Infection, Gonococcal Infection, Trichomoniasis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03852316?
The interventions under investigation include: Click Device (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03852316?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03852316 being conducted?
This trial has 10 study locations across California, Florida, Illinois, Maryland, Mississippi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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