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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age21-65
SponsorMorehouse School of Medicine

About this trial

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

Qualifiers

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

Disqualifiers

Participants currently on menses

Inability to provide Informed Consent

Previous total hysterectomy

History of radiation treatment for cervical cancer

Trial design

Treatments tested in this trial

  • Pap smear collection using the Personal Pap Smear (PPS) Device
  • Active Comparator: Pap smear collection using the Rovers Cervex-Brush

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Morehouse School of Medicine

Lead sponsor

GyneConcepts, Inc.

Collaborator