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

Morehouse School of Medicine

Status: Enrolling

Conditions: Cervical Cancer Screening

Treatments: Device: Active Comparator: Pap smear collection using the Rovers Cervex-Brush; Device: Pap smear collection using the Personal Pap Smear (PPS) Device

Study type: Interventional

Funder types: Other

Identifiers

NCT06229275

2011440

Details and patient eligibility

About

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).

Full 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).

Enrollment: 200 estimated patients

Sex: Female

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

200 participants in 2 patient groups

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

Experimental group

Description:

The investigational device, trade named the Personal Pap Smear™ (PPS) developed by GyneConcepts of Atlanta, Georgia. It arrives completely assembled, and ready-for-use, in a sealed plastic bag. The PPS device is a multi-component assembly designed for the collection of exfoliated cervical epithelial cells. Its four major components are the (1) Tube Body, (2) U-Ring and attached Aligning Spoon, (3) Ball Handle, (with permanently anchored bristle Collection Brush), and (4) Safety Cover.

Treatment:

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

Pap smear collection using the Rovers Cervex-Brush

Active Comparator group

Description:

The Predicate device utilized in this study is the Cervix-Examination Brush, manufactured by Rover (Manufacturers Code: 9443). The Cervex-Brush (CervixExamination Brush) is made of polyethylene and has a total length of 20 centimeters. The top portion uses a soft flexible brush to obtain cell samples. The brush consists of 57 semi-circular plastic bristles of various lengths. The shape is such that the top edges of the brush follow the contours of the cervix. The longer middle bristles reach deep into the endocervical canal- 'Os'. The shorter bristles touch both the ectocervical area and transformation zone at the same time. This device is packaged with identical standards used for packaging commercial tampons.

Treatment:

Device: Active Comparator: Pap smear collection using the Rovers Cervex-Brush