A Study to Evaluate the Effectiveness of the Rover Cervex-Brush Device vs. the Personal Pap Smear Device™ for Collection of Cervical Cells for Detecting Cervical Dysplasia or Neoplasia
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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).
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 21
Maximum Age: 65
Healthy Volunteers: t
View:
• 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
Locations
United States
Georgia
Morehouse School of Medicine
RECRUITING
Atlanta
Contact Information
Primary
Regina K Leonis, MD
rleonis@msm.edu
4047565713
Backup
LaShawn Mays, MSM
lmays@msm.edu
4047521971
Time Frame
Start Date: 2024-07-25
Estimated Completion Date: 2026-03-30
Participants
Target number of participants: 200
Treatments
Experimental: Pap smear collection using the Personal Pap Smear (PPS) Device
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.
Active_comparator: Pap smear collection using the Rovers Cervex-Brush
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.
Related Therapeutic Areas
Sponsors
Leads: Morehouse School of Medicine
Collaborators: GyneConcepts, Inc.