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NCT01234480 · ClinicalTrials.gov registry record

Intended Use Study of the BD SurePath Plus™ Pap

A clinical trial, sponsored by Becton, Dickinson and Company.

Terminated
Registry status
5,859
Enrollment target

NCT01234480 is a clinical trial that was terminated before completion, run by Becton, Dickinson and Company. The registered enrollment target is 5,859 participants.

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The verdict

NCT01234480 was terminated before completion, sponsored by Becton, Dickinson and Company.

TERMINATED
Registry status
5,859 participants
Enrollment target

Study 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).

Interventions

  • DEVICE BD SurePath Plus Pap test
  • DEVICE BD SurePath Pap test
  • PROCEDURE colposcopy with biopsy/ECC
  • DEVICE HPV DNA test

Trial Details

FieldValue
Enrollment Target 5,859 participants
Start Date 2010-09
Est. Completion 2012-08

Sponsor

Becton, Dickinson and Company

33 total trials

What the Registry Record Tells You About NCT01234480

The ClinicalTrials.gov registry entry for NCT01234480 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 5,859 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Becton, Dickinson and Company, which has 33 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which BD SurePath Plus Pap test is the first listed.

NCT01234480 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01234480 about?

NCT01234480 is a clinical study titled "Intended Use Study of the BD SurePath Plus™ Pap". 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...

What is the current status of trial NCT01234480?

This trial is currently terminated. The enrollment target is 5,859 participants. The study started on 2010-09. Estimated completion is 2012-08.

What interventions are being tested in trial NCT01234480?

The interventions under investigation include: BD SurePath Plus Pap test (DEVICE), BD SurePath Pap test (DEVICE), colposcopy with biopsy/ECC (PROCEDURE), HPV DNA test (DEVICE).

Who is sponsoring clinical trial NCT01234480?

This trial is sponsored by Becton, Dickinson and Company, which has 33 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.