Recruiting

Personal Pap Smear Device™ vs. Rover Cervex-Brush

Sponsor:

Morehouse School of Medicine

Code:

NCT06229275

Conditions

Cervical Cancer Screening

Eligibility Criteria

Sex: Female

Age: 21 - 65

Healthy Volunteers: Accepted

Interventions

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

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

Study Details

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

Study ID

NCT06229275

Start date

Jul 25, 2024

Status verified date

Jul, 2025

Completion date

Mar 30, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21 - 65

Healthy Volunteers: Accepted

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

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Screening

Interventions and Outcome Measures

Arms

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.

Interventions

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

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

Primary outcome measure

  • Comparison of the samples for the Predicate Device versus PPS device [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Regina K Leonis, MD

4047565713rleonis@msm.edu

LaShawn Mays, MSM

4047521971lmays@msm.edu

Locations

Morehouse School of Medicine

Recruiting

Atlanta, Georgia, United States, 30310

Contacts

Regina Leonis, MD

4047893839rleonis@msm.edu

LaShawn Mays, MSM

4047521971lmays@msm.edu

More Information

Sponsor

Morehouse School of Medicine

Last update posted

Jul 20, 2025

Last verified

Jul, 2025

Keywords

  • pap smear collection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Morehouse School of Medicine on 2025-07-20.