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

NCT06229275 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-07-20

No results posted yet for this study

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).

Conditions

  • Cervical Cancer Screening

Interventions

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.

Sponsors & Collaborators

  • GyneConcepts, Inc.

    collaborator UNKNOWN

  • Morehouse School of Medicine

    lead OTHER

Principal Investigators

  • Regina K Leonis, MD, MD · Morehouse School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-25
Primary Completion
2025-12-31
Completion
2026-03-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06229275 on ClinicalTrials.gov