NCT06229275

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Morehouse School of Medicine · Academic / Other
• Sex: Female
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

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).

Conditions

• Cervical Cancer Screening

Interventions

Type	Name	Description
DEVICE	Pap smear collection using the Personal Pap Smear (PPS) Device	Diagnostic Test: Use of PPS device to collect cervical cells during pap smear collection.
DEVICE	Active Comparator: Pap smear collection using the Rovers Cervex-Brush	Diagnostic Test: Use of Rovers Cervex-Brush to collect cervical cells during pap smear collection.

Timeline

• Start date: 2024-07-25
• Primary completion: 2025-12-31
• Completion: 2026-03-30
• First posted: 2024-01-29
• Last updated: 2025-07-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study