Trials / Completed
CompletedNCT01671462
European Clinical Evaluation of the BD HPV Assay on the BD Viper LT System
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,365 (actual)
- Sponsor
- Becton, Dickinson and Company · Industry
- Sex
- Female
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to compare the results of the Becton Dickinson (BD) Human Papilloma Virus (HPV) Assay on the Viper LT instrument from SurePath media diluted in HPV diluent (pre-quot and/or residual), PreservCyt media diluted in HPV diluent (pre-quot and/or residual) and a BD cervical brush in BD transport medium to reference histology results from biopsy.
Detailed description
This is a multicenter study consisting of 2-3 European clinical trial sites, and up to 2 BD Viper LT Systems. The BD HPV Diluent tube will be run on the BD HPV assay with the Viper LT instrument and compared to histology, Digene hybrid capture 2 (HC2), and Roche LINEAR ARRAY HPV Genotyping Test results.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | BD HPV assay on Viper LT |
Timeline
- Start date
- 2012-08-01
- Primary completion
- 2013-11-01
- Completion
- 2013-11-01
- First posted
- 2012-08-23
- Last updated
- 2014-02-20
Locations
2 sites across 2 countries: Denmark, Italy
Source: ClinicalTrials.gov record NCT01671462. Inclusion in this directory is not an endorsement.