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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06229275

Enrollment

200

Registered

2024-01-29

Start date

2024-07-25

Completion date

2026-03-30

Last updated

2025-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer Screening

Keywords

pap smear collection

Brief summary

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).

Detailed description

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).

Interventions

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

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

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

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

21 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Comparison of the samples for the Predicate Device versus PPS device	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

Measure	Time frame	Description
The Comparison of Cell Types of the PPS Device versus the Predicate Device	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.

Countries

United States

Contacts

Primary ContactRegina K Leonis, MD

rleonis@msm.edu4047565713

Backup ContactLaShawn Mays, MSM

lmays@msm.edu4047521971

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026