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

NCT06229275 | Recruiting FDA Device

• 1 other identifier: 2011440
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Cervical Cancer Screening

Keywords

pap smear collection

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline

Secondary Outcomes (1)

• The Comparison of Cell Types of the PPS Device versus the Predicate Device

  Baseline

Study Arms (2)

Pap smear collection using the Personal Pap Smear (PPS) Device

EXPERIMENTAL

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

Pap smear collection using the Rovers Cervex-Brush

ACTIVE COMPARATOR

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

Interventions

Pap smear collection using the Personal Pap Smear (PPS) Device DEVICE

Diagnostic Test: Use of PPS device to collect cervical cells during pap smear collection.

Pap smear collection using the Personal Pap Smear (PPS) Device

Active Comparator: Pap smear collection using the Rovers Cervex-Brush DEVICE

Diagnostic Test: Use of Rovers Cervex-Brush to collect cervical cells during pap smear collection.

Pap smear collection using the Rovers Cervex-Brush

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Morehouse School of Medicine: lead
• GyneConcepts, Inc.: collaborator

Study Sites (1)

Morehouse School of Medicine

Atlanta, Georgia, 30310, United States

RECRUITING

Study Officials

• Regina K Leonis, MD, MD

  Morehouse School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Regina K Leonis, MD

CONTACT

4047565713; rleonis@msm.edu

LaShawn Mays, MSM

CONTACT

4047521971; lmays@msm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 29, 2024
• Study Start: July 25, 2024
• Primary Completion: December 31, 2025
• Study Completion: March 30, 2026
• Last Updated: July 20, 2025

Record last verified: 2025-07

Locations

US (1)