NCT06229275NARecruitingAccepts Healthy Volunteers

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

Morehouse School of Medicine

Start Date

7/25/2024

Completion Date

3/30/2026

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).

Detailed Description

To determine the effectiveness of the Personal Pap Smear Device™ to collect adequate (as defined by Bethesda Guidelines 2014) cervical cell samples for cytology examination as compared with the Rover Cervex-Brush (Cervix-Examination Brush).

Eligibility Criteria

Age Range: 21 years to 65 years

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

Interventions

DEVICE

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

DEVICE

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

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Conditions

Cervical Cancer Screening

Locations

Morehouse School of Medicine

Atlanta, Georgia 30310

United States