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
Morehouse School of Medicine
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).
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
- Age range
- 21–65 years
- Sex
- Female
- Healthy volunteers
- Yes
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
- 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.
Location
- Morehouse School of MedicineAtlanta, Georgia