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

November 16, 2009 updated by: CytoCore, Inc.

Clinical Study Validating the Adequacy, Efficacy, and Safety of the e2TM Cervical Cell Collector Compared to Standard Spatula/CytoBrush Technique In Patients With Recent History of Abnormal Pap Test Returning for Colposcopy/Biopsy.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The e2TM (SoftPAP) Collector collects only cells that have been exfoliated from the cervix whereas spatulas, brushes and broom-style collection devices collect cells by scraping or abrading the cervix. THis trial is to determine whether the purely exfoliated sample collected using the e2TM Collector is equivalent to samples obtained by scraping or abrading the cervix for purposes of cervical cancer screening and HPV detection.

Study Type

Observational

Enrollment (Actual)

737

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Wellington, Florida, United States, 33414
        • Visions Clinical Research
      • West Palm Beach, Florida, United States, 33409
        • Comprehensive Clinical Trials
    • Missouri
      • St. Louis, Missouri, United States, 63106
        • St. Louis University
    • Ohio
      • Cincinnati, Ohio, United States, 45206
        • University of Cincinnati
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Centers
    • Texas
      • Fort Worth, Texas, United States, 75246
        • Baylor Research Institute
    • Virginia
      • Norfolk, Virginia, United States, 23510
        • Eastern Virginia Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women > 18 years of age with an abnormal pap within 30 days to 1 year for whom a colposcopy is scheduled.

Description

Inclusion Criteria:

  • Women ages 18 years old and above
  • Women scheduled to undergo colposcopy

Exclusion Criteria:

  • Patients who have had a hysterectomy
  • Patients who are pregnant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Arm 1 - Experimental
e2 Cell Collector [SoftPAP(R)]
Device: e2 Cell Collector [SoftPAP(R)]
Cervical cells collected using the e2 Cell Collector [SoftPAP(R)]
Arm 2 - Control
Brush/spatula
Device: Spatula/Brush
Cervical cells collected using a combination of a cervical spatula and an endocervical brush

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cell Collection Efficacy
Time Frame: At the time of cell collection.
True Positive (TP); True Negative (TN), False Positive (FP) and False Negative (FN) participants and percentage of participants based upon comparison of the cytology diagnosis (Dx) with biopsy (Bx) and endocervical curretage (ECC) results from the same patient.
At the time of cell collection.
Specimen Adequacy
Time Frame: At time of cell collection
Number and percentage of samples classified as adequate for diagnosis
At time of cell collection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Human Papilloma Virus (HPV) Detection Frequency
Time Frame: At the time of cell collection.
Number and percentage of HPV positive specimens by the Hybrid Capture II (HC-II) assay
At the time of cell collection.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CytoCore, Inc.

Collaborators

University Hospitals Cleveland Medical Center

Investigators

  • Principal Investigator: Jay S. Pinkerton, MD, University Hospitals Cleveland Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

May 16, 2007

First Submitted That Met QC Criteria

May 16, 2007

First Posted (Estimate)

May 17, 2007

Study Record Updates

Last Update Posted (Estimate)

November 20, 2009

Last Update Submitted That Met QC Criteria

November 16, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • e2TM Cervical cell Collector

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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