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).
Adult women, aged 21-65 years old.
Do not have any medical or psychiatric condition affecting the ability to give voluntary informed consent.
Be able to read and understand English
Participants currently on menses
Inability to provide Informed Consent
Previous total hysterectomy
History of radiation treatment for cervical cancer
Crossover
Pap smear collection using the Personal Pap Smear (PPS) Device
DeviceDiagnostic Test: Use of PPS device to collect cervical cells during pap smear collection.
Active Comparator: Pap smear collection using the Rovers Cervex-Brush
DeviceDiagnostic Test: Use of Rovers Cervex-Brush to collect cervical cells during pap smear collection.
Comparison 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.
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.
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Morehouse School of Medicine
Lead sponsor
GyneConcepts, Inc.
Collaborator
