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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00474968
Recruitment Status : Completed
First Posted : May 17, 2007
Results First Posted : August 13, 2009
Last Update Posted : November 20, 2009
University Hospitals Cleveland Medical Center
Information provided by:
CytoCore, Inc.

Brief 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

Condition or disease Intervention/treatment
Colposcopy Biopsy Device: e2 Cell Collector [SoftPAP(R)] Device: Spatula/Brush

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.

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Study Type : Observational
Actual Enrollment : 737 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: 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.
Study Start Date : April 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

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
Device: Spatula/Brush
Cervical cells collected using a combination of a cervical spatula and an endocervical brush

Primary Outcome Measures :
  1. 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.

  2. Specimen Adequacy [ Time Frame: At time of cell collection ]
    Number and percentage of samples classified as adequate for diagnosis

Secondary Outcome Measures :
  1. 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

Biospecimen Retention:   None Retained
Cervical cells

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00474968

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United States, Florida
Visions Clinical Research
Wellington, Florida, United States, 33414
Comprehensive Clinical Trials
West Palm Beach, Florida, United States, 33409
United States, Missouri
St. Louis University
St. Louis, Missouri, United States, 63106
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45206
United States, Pennsylvania
University of Pittsburgh Medical Centers
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Baylor Research Institute
Fort Worth, Texas, United States, 75246
United States, Virginia
Eastern Virginia Medical School
Norfolk, Virginia, United States, 23510
Sponsors and Collaborators
CytoCore, Inc.
University Hospitals Cleveland Medical Center
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Principal Investigator: Jay S. Pinkerton, MD University Hospitals Cleveland Medical Center

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Responsible Party: Richard Domanik, CytoCore Identifier: NCT00474968    
Other Study ID Numbers: e2TM Cervical cell Collector
First Posted: May 17, 2007    Key Record Dates
Results First Posted: August 13, 2009
Last Update Posted: November 20, 2009
Last Verified: November 2009