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Intended Use Study of the BD SurePath Plus™ Pap

NCT01234480 · Status: TERMINATED · Type: INTERVENTIONAL · Enrollment: 5859

Last updated 2023-05-16

Study results available
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Summary

This study will provide data on the performance of the BD SurePath Plus™ Pap test for identifying high grade cervical disease. This study will be conducted with approximately 12,500 women undergoing routine cervical cancer screening, of whom women with abnormal cytology and/or positive HPV test will be selected to undergo colposcopy and biopsy/ECC. Subjects with abnormal cytology results with biopsy results of less than or equal to CIN1 or CIN2 untreated will be asked to return in 6-8 months for follow-up testing. Subjects may be asked to proceed to a longer-term follow-up study and undergo cytological evaluation annually for 3 years (separate study).

Conditions

  • Uterine Cervical Neoplasms
  • Uterine Cervical Cancer
  • Neoplasms, Squamous Cell
  • Neoplasms, Glandular and Epithelial
  • Neoplasms by Histologic Type
  • Neoplasms
  • Papilloma

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

Sponsors & Collaborators

  • Becton, Dickinson and Company

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-03-31
Completion
2012-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01234480 on ClinicalTrials.gov