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Clinical Study of a Diagnostic Device for NG, TV and CT in Women

NCT03852316 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1585

Last updated 2022-01-13

Study results available
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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

  • Chlamydial Infection
  • Gonococcal Infection
  • Trichomoniasis

Interventions

DEVICE

Click Device

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.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-27
Primary Completion
2019-12-02
Completion
2019-12-02
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03852316 on ClinicalTrials.gov