Trials / Completed
CompletedNCT02267876
Longitudinal Clinical Evaluation of the HPV Assay on the BD VIPER LT System With Cervical Specimens
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 6,730 (actual)
- Sponsor
- Becton, Dickinson and Company · Industry
- Sex
- Female
- Age
- 21 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2014-10-01
- Primary completion
- 2018-12-12
- Completion
- 2019-05-01
- First posted
- 2014-10-20
- Last updated
- 2021-02-08
Locations
40 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT02267876. Inclusion in this directory is not an endorsement.