An interventional study of Pap smear collection using the Personal Pap Smear (PPS) Device and Active Comparator: Pap smear collection using the Rovers Cervex-Brush in Cervical Cancer Screening, sponsored by Morehouse School of Medicine. Recruiting at 1 site in United States. Open to female participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-20.
Sponsored by Morehouse School of Medicine · Not applicable, Interventional, and Screening
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).
Morehouse School of Medicine is the lead sponsor of 22 studies on the registry; 11 are open to participants now.
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The investigational device, trade named the Personal Pap Smear™ (PPS) developed by GyneConcepts of Atlanta, Georgia. It arrives completely assembled, and ready-for-use, in a sealed plastic bag. The PPS device is a multi-component assembly designed for the collection of exfoliated cervical epithelial cells. Its four major components are the (1) Tube Body, (2) U-Ring and attached Aligning Spoon, (3) Ball Handle, (with permanently anchored bristle Collection Brush), and (4) Safety Cover.
Device: Pap smear collection using the Personal Pap Smear (PPS) Device
The Predicate device utilized in this study is the Cervix-Examination Brush, manufactured by Rover (Manufacturers Code: 9443). The Cervex-Brush (CervixExamination Brush) is made of polyethylene and has a total length of 20 centimeters. The top portion uses a soft flexible brush to obtain cell samples. The brush consists of 57 semi-circular plastic bristles of various lengths. The shape is such that the top edges of the brush follow the contours of the cervix. The longer middle bristles reach deep into the endocervical canal- 'Os'. The shorter bristles touch both the ectocervical area and transformation zone at the same time. This device is packaged with identical standards used for packaging commercial tampons.
Device: Active Comparator: Pap smear collection using the Rovers Cervex-Brush
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.
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.
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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