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Recruiting NCT06229275

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

Trial Parameters

Condition Cervical Cancer Screening
Sponsor Morehouse School of Medicine
Study Type INTERVENTIONAL
Phase N/A
Enrollment 200
Sex FEMALE
Min Age 21 Years
Max Age 65 Years
Start Date 2024-07-25
Completion 2025-12-31
Interventions
Pap smear collection using the Personal Pap Smear (PPS) DeviceActive Comparator: Pap smear collection using the Rovers Cervex-Brush

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

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