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NCT05063344 · ClinicalTrials.gov registry record
NOWDx Test for the Diagnosis of Syphilis
A clinical trial of Syphilis Infection and Treponema Pallidum Infection, sponsored by NOWDiagnostics.
- Completed
- Registry status
- 1,535
- Enrollment target
- 6
- Study locations
NCT05063344: Completed study of Syphilis Infection and Treponema Pallidum Infection, sponsored by NOWDiagnostics.
NCT05063344 is a study of Syphilis Infection and Treponema Pallidum Infection that has completed, run by NOWDiagnostics. The registered enrollment target is 1,535 participants. The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05063344, a study of Syphilis Infection and Treponema Pallidum Infection, has completed, sponsored by NOWDiagnostics.
- COMPLETED
- Registry status
- 1,535 participants
- Enrollment target
- 6
- Study locations
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.
Primary Outcome
The comparator method used in this study is an algorithm comprised of results from three different commercially available syphilis assays: an FDA-cleared treponemal immunoassay, an FDA-cleared non-treponemal assay (RPR assay) and a second treponemal assay (TP-PA).
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 |
What the finished NCT05063344 record still lists
NCT05063344 is an observational study that tracks outcomes without assigning an intervention. Its 1,535 participants enrollment target places it among the larger protocols in the corpus.
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.
NCT05063344 lists 6 locations in 6 states (Arizona, California, Florida).
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.
What interventions are being tested in trial NCT05063344?
The interventions under investigation include: Diagnostic Test: NOWDx Syphilis Test (DEVICE).
Who is sponsoring clinical trial NCT05063344?
This trial is sponsored by NOWDiagnostics, which has 4 total clinical trials registered on ClinicalTrials.gov.
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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