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.
Observational Model: Case Control, Time Perspective: Prospective
Cell Collection Efficacy
At the time of cell collection.
Jay S. Pinkerton, MD
University Hospital Case Medical Center
United States: Institutional Review Board
e2TM Cervical cell Collector
|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|