RECRUITINGINTERVENTIONAL
Comparing Effectiveness of Physician-assisted Versus Self-assisted Pap Smear Collection
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
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).
Who May Be Eligible (Plain English)
Who May Qualify:
- Adult women, aged 21-65 years old.
- Do not have any medical or psychiatric condition affecting the ability to give voluntary willing to sign a consent form.
- Be able to read and understand English
Who Should NOT Join This Trial:
- Participants currently on menses
- Inability to provide willing to sign a consent form
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DEVICE
Pap smear collection using the Personal Pap Smear (PPS) Device
Diagnostic Test: Use of PPS device to collect cervical cells during pap smear collection.
DEVICE
Active Comparator: Pap smear collection using the Rovers Cervex-Brush
Diagnostic Test: Use of Rovers Cervex-Brush to collect cervical cells during pap smear collection.
Locations (1)
Morehouse School of Medicine
Atlanta, Georgia, United States