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

M

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

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

200 participants in 2 patient groups

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

Trial contacts and locations

0

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Central trial contact

Jan Morgan-Billingslea; Regina K Leonis, MD

Data sourced from clinicaltrials.gov

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