Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT06229275

Recruiting

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

Interventional

Phase not listed

Morehouse School of Medicine

Sponsor: Morehouse School of Medicine

Last Updated: July 20, 2025
Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.

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).

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Treatment Category

Device

Required Mutations

None

Trial Started

July 25, 2024

Last Updated by Sponsor

July 20, 2025

Estimated Completion

December 31, 2025

Contact Study

Name:Regina K Leonis, MD

Email:rleonis@msm.edu

Phone:4047565713

Name:LaShawn Mays, MSM

Email:lmays@msm.edu

Phone:4047521971

Eligibility

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

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Design Details

AllocationRandomized

Intervention ModelCrossover Assignment

MaskingNone (Open Label)

Number to Enroll200

Arms & Interventions

Arms

Interventions

Type: Experimental

Description: The investigational device, trade named the Personal Pap Smear™ (PPS) developed by GyneConcepts of Atlanta, Georgia. It arrives completely assembled, and ready-for-use, in a sealed plastic bag. The PPS device is a multi-component assembly designed for the collection of exfoliated cervical epithelial cells. Its four major components are the (1) Tube Body, (2) U-Ring and attached Aligning Spoon, (3) Ball Handle, (with permanently anchored bristle Collection Brush), and (4) Safety Cover.

Interventions:

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

Outcome Measures

Primary Outcome Measures

Comparison of the samples for the Predicate Device versus PPS deviceBaseline

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 Outcome Measures

The Comparison of Cell Types of the PPS Device versus the Predicate DeviceBaseline

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.

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Trial Sites

This study has 1 trial site

Morehouse School of Medicine

Atlanta, Georgia, US

Name:Regina Leonis, MD

Email:rleonis@msm.edu

Phone:4047893839

Recruiting

Atlanta, Georgia, 30310 US

Morehouse School of Medicine

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