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.
18 Years
N/A
Female
Colposcopy, Biopsy
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 School | Norfolk, Virginia 23507 |
| Baylor Research Institute | Dallas, Texas 75246 |
| St. Louis University | St. Louis, Missouri 63110 |
| University of Cincinnati | Cincinnati, Ohio 45267-0502 |
| Visions Clinical Research | Boynton Beach, Florida 33472 |
| Comprehensive Clinical Trials | West Palm Beach, Florida 33409 |
| University of Pittsburgh Medical Centers | Pittsburgh, Pennsylvania 15213 |
