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Adequacy and Efficacy of the e2TM Cervical Cell Collector Compared to Standard Spatula/CytoBrush Technique.

NCT00474968 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 737

Last updated 2009-11-20

Study results available
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Summary

A clinical study to determine the adequacy and efficacy of the InPath e2TM Collector compared to the FDA-approved spatula/cytobrush when used as the cell collection device in screening for cervical cancer.

The InPath e2TM Collector name has been changed to the CytoCore SoftPAP(R) Collector

Conditions

  • Colposcopy
  • Biopsy

Interventions

DEVICE

e2 Cell Collector [SoftPAP(R)]

Cervical cells collected using the e2 Cell Collector \[SoftPAP(R)\]

DEVICE

Spatula/Brush

Cervical cells collected using a combination of a cervical spatula and an endocervical brush

Sponsors & Collaborators

  • University Hospitals Cleveland Medical Center

    collaborator OTHER

  • CytoCore, Inc.

    lead INDUSTRY

Principal Investigators

  • Jay S. Pinkerton, MD · University Hospitals Cleveland Medical Center

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2008-05-31
Completion
2008-05-31

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 NCT00474968 on ClinicalTrials.gov