This purpose of this research study is to determine the effectiveness of the Personal Pap Smear Device™ to collect adequate cervical cell samples for cytology examination when compared with the Rover Cervex-Brush (Cervix-Examination Brush).
To determine the effectiveness of the Personal Pap Smear Device™ to collect adequate (as defined by Bethesda Guidelines 2014) cervical cell samples for cytology examination as compared with the Rover Cervex-Brush (Cervix-Examination Brush).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
200
Diagnostic Test: Use of PPS device to collect cervical cells during pap smear collection.
Diagnostic Test: Use of Rovers Cervex-Brush to collect cervical cells during pap smear collection.
Morehouse School of Medicine
Atlanta, Georgia, United States
RECRUITINGComparison of the samples for the Predicate Device versus PPS device
Data of Adequate versus Inadequate will be reported to include a positive percent agreement (PPA) defined as PPA= A/(A+C) and the negative percent agreement (NPA) defined as NPA = D/(B+D) along with their 95% confidence bounds using the Clopper-Pearson method.
Time frame: Baseline
The Comparison of Cell Types of the PPS Device versus the Predicate Device
The PPS Device and the Predicate Device cell types will be measured against the 2014 Bethesda cytology categories that will be displayed in a 8 x 8 contingency table.
Time frame: Baseline
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