Actively Recruiting
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
Led by Morehouse School of Medicine · Updated on 2025-07-20
200
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
Sponsors
M
Morehouse School of Medicine
Lead Sponsor
G
GyneConcepts, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to compare the effectiveness of two devices in collecting cervical cell samples for cytology examination to detect cervical dysplasia or neoplasia. The study focuses on adult women aged 21 to 65 undergoing cervical cancer screening, evaluating how well the Personal Pap Smear Device™ collects samples compared to the Rover Cervex-Brush (Cervix-Examination Brush). The goal is to determine which device provides adequate samples following the Bethesda Guidelines 2014. The study includes two groups: one using the Personal Pap Smear Device™, a multi-component tool designed for cervical cell collection, and the other using the Rover Cervex-Brush, a flexible brush with bristles shaped to follow the cervix contour. Both devices are used during pap smear collection to gather exfoliated cervical epithelial cells. The Personal Pap Smear Device™ arrives ready to use, and the Rover Cervex-Brush is a commercially packaged comparator device. Participants will undergo pap smear collection with one of the devices, and the collected samples will be analyzed for adequacy and cell types. Researchers will compare samples from both devices to measure effectiveness. The study involves random assignment to either device group, with no masking. Participants are monitored for safety and sample quality, with data collected at baseline. The study lasts for the necessary duration to complete these assessments and ensure proper monitoring.
CONDITIONS
Brief Title
Comparing Effectiveness of Physician-assisted Versus Self-assisted Pap Smear Collection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult women, aged 21-65 years old
- Able to give voluntary informed consent without medical or psychiatric conditions affecting consent
- Able to read and understand English
You will not qualify if you...
- Currently menstruating
- Unable to provide informed consent
- Previous total hysterectomy
- History of radiation treatment for cervical cancer
- Pregnant
- Medical condition interfering with study conduct, as judged by investigator
- Active cervical infection requiring treatment
- Known bleeding disorder
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo pap smear collections using two different devices to compare sample adequacy for detecting cervical abnormalities.
1 visit (in-person) with crossover device use
Trial Site Locations
Total: 1 location
1
Morehouse School of Medicine
Atlanta, Georgia, United States, 30310
Actively Recruiting
Research Team
R
Regina K Leonis, MD
L
LaShawn Mays, MSM
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
SCREENING
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here