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

Becton, Dickinson and Company (BD)

Status: Completed

Conditions: Cervical Neoplasms; Human Papillomavirus

Treatments: Device: BD HPV Assay on Viper LT; Procedure: Colposcopy

Study type: Observational

Funder types: Industry

Identifiers

NCT02267876

BDS-USLHPV

Details and patient eligibility

About

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

Enrollment: 6,730 patients

Sex: Female

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject enrolled into the protocol BDS-USHPV and identified as eligible for the longitudinal protocol • Subjects enrolled into protocol BDS-USHPV with a baseline colposcopy and biopsy procedure and not treated.

Exclusion criteria

• Subjects with prior complete or partial hysterectomy involving removal of the cervix
• Subjects on whom conization, LEEP, cervical laser surgery, or cryosurgery has been performed since enrollment into the BDS-USHPV study
• Year 3 visit can not exceed 3 years and 6 months from the baseline visit

Trial design

6,730 participants in 1 patient group

BD VIPER LT

Treatment:

Procedure: Colposcopy

Device: BD HPV Assay on Viper LT