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NCT Number: NCT06229275

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

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).

Recruiting

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Key information

Conditions

Cervical Cancer Screening

Age range

21 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Diagnostic Test: Use of PPS device to collect cervical cells during pap smear collection.

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

Device

Diagnostic Test: Use of Rovers Cervex-Brush to collect cervical cells during pap smear collection.

Primary outcomes

  1. Comparison of the samples for the Predicate Device versus PPS device

    Time frame: Baseline

    Data of Adequate versus Inadequate will be reported to include a positive percent agreement (PPA) defined as PPA= A/(A+C) and the negative percent agreement (NPA) defined as NPA = D/(B+D) along with their 95% confidence bounds using the Clopper-Pearson method.

Secondary outcomes

  1. The Comparison of Cell Types of the PPS Device versus the Predicate Device

    Time frame: Baseline

    The PPS Device and the Predicate Device cell types will be measured against the 2014 Bethesda cytology categories that will be displayed in a 8 x 8 contingency table.

Study contacts

Contact information is provided by the study sponsor or research team.

LaShawn Mays, MSM

CONTACT

[email protected]

4047521971

Regina K Leonis, MD

CONTACT

[email protected]

4047565713

Sponsors and collaborators

Lead sponsor

Morehouse School of Medicine

Other

Collaborators

  • GyneConcepts, Inc.

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 29, 2024
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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