MedTrace Logo

Longitudinal Clinical Evaluation of the HPV Assay on the BD VIPER LT System With Cervical Specimens

NCT02267876 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 6730

Last updated 2021-02-08

No results posted yet for this study

Summary

The purpose of the study is to assess the cumulative disease detection of greater than or equal to Cervical intraepithelial neoplasia 2 (CIN2) and greater than or equal to Cervical intraepithelial neoplasia 3 (CIN3) in the subjects over 3 years using the subject's HPV status and cytology status from the BDS-USHPV baseline results

Conditions

  • Cervical Neoplasms
  • Human Papillomavirus

Interventions

DEVICE

BD HPV Assay on Viper LT

The BD HPV specimen will be tested with the BD HPV Assay on the Viper LT instrument.

PROCEDURE

Colposcopy

The colposcopy will be performed on subjects that have abnormal cytology. At the third year visit all subjects will have an exit colposcopy.

Sponsors & Collaborators

  • Becton, Dickinson and Company

    lead INDUSTRY

Principal Investigators

  • Tobi Karchmer, MD · Becton, Dickinson and Company

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2018-12-12
Completion
2019-05-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

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 NCT02267876 on ClinicalTrials.gov