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

July 16, 2025 updated by: Regina Leonis, Morehouse School of Medicine

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Regina K Leonis, MD
  • Phone Number: 4047565713
  • Email: rleonis@msm.edu

Study Contact Backup

  • Name: LaShawn Mays, MSM
  • Phone Number: 4047521971
  • Email: lmays@msm.edu

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30310
        • Recruiting
        • Morehouse School of Medicine
        • Contact:
          • LaShawn Mays, MSM
          • Phone Number: 4047521971
          • Email: lmays@msm.edu
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the samples for the Predicate Device versus PPS device
Time Frame: Baseline
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Comparison of Cell Types of the PPS Device versus the Predicate Device
Time Frame: Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Morehouse School of Medicine

Collaborators

GyneConcepts, Inc.

Investigators

  • Principal Investigator: Regina K Leonis, MD, MD, Morehouse School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

March 30, 2026

Study Registration Dates

First Submitted

January 10, 2024

First Submitted That Met QC Criteria

January 19, 2024

First Posted (Actual)

January 29, 2024

Study Record Updates

Last Update Posted (Actual)

July 20, 2025

Last Update Submitted That Met QC Criteria

July 16, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011440

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cervical Cancer Screening

Clinical Trials on Pap smear collection using the Personal Pap Smear (PPS) Device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe