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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Morehouse School of Medicine
Study ID
NCT06229275
Status
Recruiting
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Conditions

  • Cervical Cancer Screening

Eligibility Criteria

Sex
FEMALE
Age
21 Years - 65 Years
Healthy Volunteers
Accepted

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.
  • 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.

Study Details

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).

Key Dates

Start date
Jul 25, 2024
Status verified
Jul 2025
Primary completion
Dec 31, 2025
Completion
Mar 30, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Morehouse School of MedicineAtlantaGeorgia30310
Regina Leonis, MD
[email protected]
4047893839
LaShawn Mays, MSM
[email protected]
4047521971

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By research site
Morehouse School of Medicine· Atlanta, GA

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