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

CompletedOBSERVATIONAL
Enrollment

6,730

Participants

Timeline

Start Date

October 31, 2014

Primary Completion Date

December 12, 2018

Study Completion Date

May 31, 2019

Conditions
Cervical NeoplasmsHuman Papillomavirus
Interventions
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.

Trial Locations (40)

10461

Montefiore Medical Center, The Bronx

10533

Research Pathology Associates, LLC, Irvington

19114

Clinical Research of Philadelphia, Philadelphia

19446

Center for Women's Health of Lansdale, Lansdale

19611

Reading Health Physician Network, West Reading

21152

BD 54 Loveton, Sparks

22901

Research Pathology Associates, Charlottesville

23462

Tidewater Clinical Research, Virginia Beach

27103

Lyndhurst Clinical Research, Winston-Salem

28562

Eastern Carolina Women's Center, New Bern

29406

James T. Martin Jr. OB/GYN, North Charleston

29910

Fellows Research Alliance - Bluffton, Bluffton

30033

Medical Network for Education & Research, Decatur

31406

Fellows Research Alliance - Savannah, Savannah

33143

Miami Research Associates, South Miami

33161

Segal Institute for Clinical Research, North Miami

33409

Comprehensive Clinical Trails, LLC, West Palm Beach

33458

Health Awareness Inc., Jupiter

33461

Altus Research, Lake Worth

35294

University of Alabama, Birmingham

36608

Mobile OB/GYN, Mobile

37404

Chattanooga Medical Research, Chattanooga

42003

Four Rivers Clinical Research, Paducah

45322

HWC Women's Research Center, Englewood

46202

Indiana University, Indianapolis

48604

Saginaw Valley Medical Research, Saginaw

61820

Women's Health Practice, Champaign

70112

Louisiana State University, New Orleans

78233

Center for Disease Detection, LLC, San Antonio

80910

Blueskies Center for Women, Colorado Springs

84020

Physicians Research Options, Draper

85015

Women's Health Research of Arizona, Phoenix

85712

Quality of Life Medical & Research Center, Tucson

Visions Clinical Research, Tucson

87102

TriCore, Albuquerque

92123

Women's Health Care Research Corp., San Diego

08057

Virtua Phoenix OB/GYN, Moorestown

07753

Meridian Health / Jersey Shore University Medical Center, Neptune City

07608

Quest Laboratories, Teterboro

H2V3J1

BioVision, Montreal

Sponsors
All Listed Sponsors
lead

Becton, Dickinson and Company

INDUSTRY