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

Cervical Cancer Screening Clinical Trial

Official title:

A Phase III Cross-Over Comparative 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06229275
• Other study ID #: 2011440
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: February 2, 2024
• Est. completion date: March 30, 2026

Study information

• Verified date: January 2024
• Source: Morehouse School of Medicine
• Contact: Regina K Leonis, MD
• Phone: 4047565713
• Email: rleonis[@]msm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: March 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 65 Years

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

Related Conditions & MeSH terms

• Cervical Cancer Screening
• Uterine Cervical Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Morehouse School of Medicine	GyneConcepts, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the samples for the Predicate Device versus PPS device	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.	Baseline
Secondary	The Comparison of Cell Types of the PPS Device versus the Predicate Device	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.	Baseline