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Diagnosing Bacterial Vaginosis/Vaginitis (BV) Using the Gynecologene Test Method

NCT02558179 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2016-07-13

No results posted yet for this study

Summary

This study is designed as a prospective evaluation of the diagnostic performance of the multiplex nucleic acid-based genetic test (Gynecologene Next-Generation Sequencing test) to identify known significant causative organisms in bacterial vaginosis/vaginitis and other major pathogens and normal commensals in symptomatic women during the reproductive years. Vaginal fluid samples will be split and tested with the comparator methods and Nugent score, with the results evaluated according to sensitivity, specificity, positive predictive value, and negative predictive value. Laboratorians performing each test will be blinded to the clinical history and any prior test results to minimize ascertainment bias.

Each subject will be followed routinely for up to 6 weeks after initial visit for vaginosis/vaginitis by telephone or office visit at the discretion of the treating physician.

Conditions

  • Vaginosis, Bacterial

Sponsors & Collaborators

  • American International Biotechnology

    lead INDUSTRY

Principal Investigators

  • David G Bostwick, MD · American International Biotechnology (AI Biotech)

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2017-03-31
Completion
2018-07-31

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 NCT02558179 on ClinicalTrials.gov