RecruitingNot ApplicableNCT06229275

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

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


Sponsor

Morehouse School of Medicine

Enrollment

200 participants

Start Date

Jul 25, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 21 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two methods of collecting Pap smear samples for cervical cancer screening: collection by a healthcare provider (standard method) versus self-collection by the patient, to see which is more effective and acceptable. **You may be eligible if...** - You are a woman between 21 and 65 years old - You do not have any medical or psychiatric condition that prevents you from giving voluntary informed consent - You can read and understand English **You may NOT be eligible if...** - You are currently on your period - You have previously had a total hysterectomy (complete uterus removal) - You have a history of radiation treatment for cervical cancer - You are pregnant - You have signs of an active cervical infection that needs treatment - You have a known bleeding disorder Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

Diagnostic Test: Use of PPS device to collect cervical cells during pap smear collection.

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

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


Locations(1)

Morehouse School of Medicine

Atlanta, Georgia, United States

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NCT06229275


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