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NOWDx Test for the Diagnosis of Syphilis
NCT05063344 · View on ClinicalTrials.gov ↗
Study Summary
This study is designed to compare the performance of the NOWDx Syphilis Test to a currently marketed device. The intent is to show the rapid test device is comparable to the currently marketed device. The NOWDx Syphilis Test is intended for qualitatively detecting the presence or absence of human antibodies to syphilis in human whole blood to aid in the diagnosis of infection caused by Treponema pallidum.
Conditions Studied
Interventions
- DEVICE Diagnostic Test: NOWDx Syphilis Test
Study Locations (6)
Arizona
- AMR Tempe — Tempe
California
- Matrix Clinical Research — Los Angeles
Florida
- Segal Trials — North Miami
Nevada
- AMR Las Vegas — Las Vegas
New Jersey
- People Care Institute — West Orange
Washington
- Multicare Rockwood — Cheney
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,535 participants |
| Start Date | 2021-10-04 |
| Est. Completion | 2023-12-11 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05063344
The ClinicalTrials.gov registry entry for NCT05063344 describes a study currently listed as completed. It is categorized as an unspecified phase, 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 1,535 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NOWDiagnostics, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Syphilis Infection appearing as the primary indexed condition, and to 1 intervention — of which Diagnostic Test: NOWDx Syphilis Test 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: NCT05063344 reports 6 study locations spanning 6 distinct geographic areas — top geographies include Arizona, California, Florida. 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 NCT05063344 about?
NCT05063344 is a clinical study titled "NOWDx Test for the Diagnosis of Syphilis". This study is designed to compare the performance of the NOWDx Syphilis Test to a currently marketed device. The intent is to show the rapid test device is comparable to the currently marketed device. The NOWDx Syphilis Test is intended for qualitatively detecting the presence or absence of human an...
What is the current status of trial NCT05063344?
This trial is currently completed. The enrollment target is 1,535 participants. The study started on 2021-10-04. Estimated completion is 2023-12-11.
What conditions does trial NCT05063344 study?
This clinical trial studies the following conditions: Syphilis Infection, Treponema Pallidum Infection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05063344?
The interventions under investigation include: Diagnostic Test: NOWDx Syphilis Test (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05063344?
This trial is sponsored by NOWDiagnostics, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05063344 being conducted?
This trial has 6 study locations across Arizona, California, Florida, Nevada, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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