At a glance
ClinicalIndex Comparison Record- ✓Female at birth (including pregnant and breastfeeding women)
- ✓Age 14 years or older at enrollment
- ✓Able to provide informed consent or have parental permission if applicable
- ✓Able to perform self-collection of one vaginal swab and permit healthcare provider collection of three additional vaginal swabs
- ✕Any medical condition, serious intercurrent illness, or circumstance that could jeopardize subject safety or interfere with study procedures per Investigator judgment
- ✕Prior enrollment in this study
- ✕Use of antiperspirants, deodorants, douches, washes, lubricants, vaginal wipes, vaginal moisturizers, or feminine hygiene spray in the genital area within 48 hours prior to enrollment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating Click Device for Chlamydial Infection and 2 related conditions. Completed, enrolled 1,585 participants across 10 sites.
Detailed 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.
Study Details
Timeline
Interventions
A single-use device containing a polymerase chain reaction (PCR)-based nucleic acid amplification test (NAAT) for detection of deoxyribonucleic acid (DNA) from Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) in self-collected vaginal specimens.