Comparing Effectiveness of Physician-assisted Versus Self-assisted Pap Smear Collection

Purpose

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).

Condition

  • Cervical Cancer Screening

Eligibility

Eligible Ages
Between 21 Years and 65 Years
Eligible Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Exclusion Criteria

  • Participants currently on menses - Inability to provide Informed Consent - Previous total hysterectomy - History of radiation treatment for cervical cancer - Pregnancy - Medical condition that interferes with conduct of study, in investigator's opinion - Evidence of active cervical infection requiring treatment - Known bleeding diathesis

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Screening
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Device: Pap smear collection using the Personal Pap Smear (PPS) Device
    Diagnostic Test: Use of PPS device to collect cervical cells during pap smear collection.
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.
  • Device: Active Comparator: Pap smear collection using the Rovers Cervex-Brush
    Diagnostic Test: Use of Rovers Cervex-Brush to collect cervical cells during pap smear collection.

Recruiting Locations

Morehouse School of Medicine
Atlanta 4180439, Georgia 4197000 30310
Contact:
Regina Leonis, MD
4047893839
rleonis@msm.edu

More Details

Status
Recruiting
Sponsor
Morehouse School of Medicine

Study Contact

Regina K Leonis, MD
4047565713
rleonis@msm.edu

Detailed Description

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).