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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.


N/A
18 Years
N/A
Not Enrolling
Female
Colposcopy, Biopsy

Thank you

Trial Information

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.


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Cell Collection Efficacy

Outcome Time Frame:

At the time of cell collection.

Safety Issue:

Yes

Principal Investigator

Jay S. Pinkerton, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Case Medical Center

Authority:

United States: Institutional Review Board

Study ID:

e2TM Cervical cell Collector

NCT ID:

NCT00474968

Start Date:

April 2007

Completion Date:

May 2008

Related Keywords:

  • Colposcopy
  • Biopsy

Name

Location

Eastern Virginia Medical SchoolNorfolk, Virginia  23507
Baylor Research InstituteDallas, Texas  75246
St. Louis UniversitySt. Louis, Missouri  63110
University of CincinnatiCincinnati, Ohio  45267-0502
Visions Clinical ResearchBoynton Beach, Florida  33472
Comprehensive Clinical TrialsWest Palm Beach, Florida  33409
University of Pittsburgh Medical CentersPittsburgh, Pennsylvania  15213