European Clinical Evaluation of the BD HPV Assay on the BD Viper LT System
NCT01671462 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1365
Last updated 2014-02-20
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.
Conditions
- Uterine Cervical Neoplasms
Interventions
- DEVICE
-
BD HPV assay on Viper LT
Sponsors & Collaborators
-
Becton, Dickinson and Company
lead INDUSTRY
Principal Investigators
-
Irene Hannet, MD · Becton, Dickinson and Company
Eligibility
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-08-31
- Primary Completion
- 2013-11-30
- Completion
- 2013-11-30
Countries
- Denmark
- Italy
Study Locations
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