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
| Arm | Description | Assigned 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. |
|
|
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. |
|
Recruiting Locations
Morehouse School of Medicine
Atlanta 4180439, Georgia 4197000 30310
Atlanta 4180439, Georgia 4197000 30310
More Details
- Status
- Recruiting
- Sponsor
- Morehouse School of Medicine
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).