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

Phase 3

Not yet recruiting

• Conditions: Cervical Cancer Screening
• Interventions: Device: Pap smear collection using the Personal Pap Smear (PPS) Device

• Registration Number: NCT06229275
• Lead Sponsor: Morehouse School of Medicine

Brief Summary

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).

Detailed 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).

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-10
• Study First Submitted QC: 2024-01-19
• Last Update Submitted: 2024-01-19
• Study First Posted: 2024-01-29
• Last Update Posted: 2024-01-29
• Study Start: 2024-02-02
• Primary Completion: 2025-12-31
• Study Completion: 2026-03-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pap smear collection using the Personal Pap Smear (PPS) Device	Pap smear collection using the Personal Pap Smear (PPS) Device	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 Besthesda cytology categories that will be displayed in a 8 x 8 contingency table.