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

This study has been completed.
Sponsor:
Collaborator:
University Hospital Case Medical Center
Information provided by:
CytoCore, Inc.
ClinicalTrials.gov Identifier:
NCT00474968
First received: May 16, 2007
Last updated: November 16, 2009
Last verified: November 2009
  Purpose

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

Study Type: Observational
Study Design: 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.

Further study details as provided by CytoCore, Inc.:

Primary Outcome Measures:
  • Cell Collection Efficacy [ Time Frame: At the time of cell collection. ] [ Designated as safety issue: Yes ]
  • Specimen Adequacy [ Time Frame: At time of cell collection ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Human Papilloma Virus (HPV) Detection Frequency [ Time Frame: At the time of cell collection. ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Cervical cells


Enrollment: 737
Study Start Date: April 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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.

Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474968

Locations
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 Hospital Case Medical Center
Investigators
Principal Investigator: Jay S. Pinkerton, MD University Hospital Case Medical Center
  More Information

Publications:

Responsible Party: Richard Domanik, CytoCore
ClinicalTrials.gov Identifier: NCT00474968     History of Changes
Other Study ID Numbers: e2TM Cervical cell Collector
Study First Received: May 16, 2007
Results First Received: May 4, 2009
Last Updated: November 16, 2009
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 30, 2014