Physician-collected versus self-collected Pap smear using a personal device
Official title: 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
Run by Morehouse School of Medicine · NCT06229275 · Data updated 2026-11-12
This test sees if the Personal Pap Smear Device lets women aged 21–65 collect cervical cell samples that are as adequate for cytology as samples taken by a clinician with a Cervex-Brush.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 21 Years to 65 Years |
| Sex | Women only |
| Enrollment | 200 (estimated) |
| Sponsor | Morehouse School of Medicine Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Atlanta, Georgia) |
| Status | Recruiting |
| Started | July 25, 2024 |
| Main results expected | December 31, 2025 |
| Study ends | March 30, 2026 |
| Registry record updated | July 20, 2025 |
| Trial ID | NCT06229275 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adult women aged 21–65 who can give informed consent, are not pregnant or menstruating, have an intact cervix, and can read English are ideal candidates.
✕Probably not a fit
People who have had a total hysterectomy, are pregnant, have active cervical infection, known bleeding disorders, or cannot provide informed consent are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults assigned to the physician-assisted arm will have cervical samples collected by a clinician using the Rover Cervex-Brush, while participants in the self-assisted arm will use the Personal Pap Smear Device™ to collect their own samples. Sample adequacy will be judged using the Bethesda Guidelines (2014) and processed for routine cytology examination. The trial is conducted at Morehouse School of Medicine and compares rates of adequate specimens between the two collection methods. Participants must be English-speaking women aged 21–65 who are not menstruating, not pregnant, and who have not had a total hysterectomy.
Why it matters
Potential benefit: If successful, the device could allow more women to collect acceptable cervical samples themselves, potentially increasing access and comfort for screening.
How similar studies have gone: Self-collection has shown promise for HPV testing, but using self-collected samples for cytology is less established and this specific device is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Morehouse School of Medicine
Atlanta, Georgia, United States Recruiting
Study contacts
- Principal investigator: Regina K Leonis, MD, MD — Morehouse School of Medicine
- Study coordinator: Regina K Leonis, MD
- Email: rleonis@msm.edu
- Phone: 4047565713
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.