Comparing Effectiveness of Physician-assisted Versus Self-assisted Pap Smear Collection
NCT ID: NCT06229275
Last Updated: 2025-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2024-07-25
2026-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SCREENING
NONE
Study Groups
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Pap smear collection using the Personal Pap Smear (PPS) Device
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.
Pap smear collection using the Personal Pap Smear (PPS) Device
Diagnostic Test: Use of PPS device to collect cervical cells during pap smear collection.
Pap smear collection using the Rovers Cervex-Brush
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
65 Years
FEMALE
Yes
Sponsors
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GyneConcepts, Inc.
UNKNOWN
Morehouse School of Medicine
OTHER
Responsible Party
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Regina Leonis
Assistant Professor
Principal Investigators
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Regina K Leonis, MD, MD
Role: PRINCIPAL_INVESTIGATOR
Morehouse School of Medicine
Locations
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Morehouse School of Medicine
Atlanta, Georgia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2011440
Identifier Type: -
Identifier Source: org_study_id
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