Intended Use Study of the BD SurePath Plus™ Pap

TerminatedINTERVENTIONAL
Enrollment

5,859

Participants

Timeline

Start Date

September 30, 2010

Primary Completion Date

March 31, 2012

Study Completion Date

August 31, 2012

Conditions
Uterine Cervical NeoplasmsUterine Cervical CancerNeoplasms, Squamous CellNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsPapilloma
Interventions
DEVICE

BD SurePath Plus Pap test

BD SurePath Plus Pap test

DEVICE

BD SurePath Pap test

BD SurePath Plus Pap test

PROCEDURE

colposcopy with biopsy/ECC

Colposcopy with biopsy/ECC for subjects with 1)BD SurePath Pap NILM, but HPV positive, or 2) BD SurePath Plus Pap test result of ASC-US or higher 3)BD SurePath Pap ASC-US or higher

DEVICE

HPV DNA test

digene HC2 HPV DNA test

Trial Locations (1)

98105

Seattle Women's: Health, Research, Gynecology, Seattle

Sponsors
All Listed Sponsors
lead

Becton, Dickinson and Company

INDUSTRY