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Recruiting NCT06229275

NCT06229275 Comparing Effectiveness of Physician-assisted Versus Self-assisted Pap Smear Collection

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Clinical Trial Summary
NCT ID NCT06229275
Status Recruiting
Phase
Sponsor Morehouse School of Medicine
Condition Cervical Cancer Screening
Study Type INTERVENTIONAL
Enrollment 200 participants
Start Date 2024-07-25
Primary Completion 2025-12-31

Eligibility & Interventions

Sex Female only
Min Age 21 Years
Max Age 65 Years
Study Type INTERVENTIONAL
Interventions
Pap smear collection using the Personal Pap Smear (PPS) DeviceActive Comparator: Pap smear collection using the Rovers Cervex-Brush

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 200 participants in total. It began in 2024-07-25 with a primary completion date of 2025-12-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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).

Eligibility 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

Contact & Investigator

Central Contact

Regina K Leonis, MD

✉ rleonis@msm.edu

📞 4047565713

Principal Investigator

Regina K Leonis, MD, MD

PRINCIPAL INVESTIGATOR

Morehouse School of Medicine

Frequently Asked Questions

Who can join the NCT06229275 clinical trial?

This trial is open to female participants only, aged 21 Years or older, up to 65 Years, studying Cervical Cancer Screening. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06229275 currently recruiting?

Yes, NCT06229275 is actively recruiting participants. Contact the research team at rleonis@msm.edu for enrollment information.

Where is the NCT06229275 trial being conducted?

This trial is being conducted at Atlanta, United States.

Who is sponsoring the NCT06229275 clinical trial?

NCT06229275 is sponsored by Morehouse School of Medicine. The principal investigator is Regina K Leonis, MD, MD at Morehouse School of Medicine. The trial plans to enroll 200 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: September 2026  ·  Data Methodology