Study to Evaluate the Effectiveness of the Personal Pap Smear Device™ for Collection of Cervical Cells

Morehouse School of Medicine

Status and phase

Not yet enrolling

Phase 3

Conditions

Cervical Cancer Screening

Treatments

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

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06229275

2011440

Details and patient eligibility

About

This purpose of this research study is to determine the effectiveness of the Personal Pap Smear TM Device to collect adequate cervical cell samples for cytology examination when compared with the Rover Cervex-Brush (Cervix-Examination Brush).

Full description

To determine the effectiveness of the Personal Pap Smear TM 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).

Enrollment

200 estimated patients

Sex

Female

Ages

21 to 65 years old

Volunteers

Accepts Healthy Volunteers

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