Cervical Cancer ScreeningNCT06229275
Comparing Effectiveness of Physician-assisted Versus Self-assisted Pap Smear Collection
A study testing Pap smear collection using the Personal Pap Smear (PPS) Device and Active Comparator: Pap smear collection using the Rovers Cervex-Brush in people with Cervical Cancer Screening, run by Morehouse School of Medicine at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer Screening
- What is being tested?
- Pap smear collection using the Personal Pap Smear (PPS) Device and Active Comparator: Pap smear collection using the Rovers Cervex-Brush
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2024to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Morehouse School of Medicine
Atlanta, Georgia, 30310
Regina Leonis, MD, 4047893839, rleonis@msm.edu
LaShawn Mays, MSM, 4047521971, lmays@msm.edu
About this study
Official title: 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
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).
Read the 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
- Being tested
- Pap smear collection using the Personal Pap Smear (PPS) Device, Active Comparator: Pap smear collection using the Rovers Cervex-Brush
- Keywords
- pap smear collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pap smear collection using the Personal Pap Smear (PPS) DeviceDevice
Diagnostic Test: Use of PPS device to collect cervical cells during pap smear collection.
Active Comparator: Pap smear collection using the Rovers Cervex-BrushDevice
Diagnostic Test: Use of Rovers Cervex-Brush to collect cervical cells during pap smear collection.
| Study group | Role | What they receive |
|---|---|---|
| Pap smear collection using the Personal Pap Smear (PPS) Device | Experimental | 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. Receives: Device: Pap smear collection using the Personal Pap Smear (PPS) Device |
| Pap smear collection using the Rovers Cervex-Brush | Active comparator | 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. Receives: Device: Active Comparator: Pap smear collection using the Rovers Cervex-Brush |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (1)
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 Bethesda cytology categories that will be displayed in a 8 x 8 contingency table.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start25 Jul 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Cancer ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Morehouse School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- GyneConcepts, Inc.
- Responsible party
- Principal investigator, Regina Leonis, Morehouse School of Medicine
- Investigators
- Regina K Leonis, MD, MD, Principal investigator, Morehouse School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06229275
- Sponsor's protocol ID
- 2011440
- Status last verified
- Jul 2025
- First submitted
- 10 Jan 2024
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06229275
- Acronym / sponsor ID
- 2011440
- Conditions
- Cervical Cancer Screening
- Keywords
- pap smear collection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Morehouse School of MedicineUniversity, hospital or other
- Collaborators
- GyneConcepts, Inc.
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pap smear collection using the Personal Pap Smear (PPS) Device | Experimental | Device: Pap smear collection using the Personal Pap Smear (PPS) DeviceThe 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 Rovers Cervex-Brush | Active comparator | Device: Active Comparator: Pap smear collection using the Rovers Cervex-BrushThe 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- Participants currently on menses
- Inability to provide Informed Consent
- Previous total hysterectomy
- History of radiation treatment for cervical cancer
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pap smear collection using the Personal Pap Smear (PPS) DeviceDiagnostic Test: Use of PPS device to collect cervical cells during pap smear collection. | Device | Pap smear collection using the Personal Pap Smear (PPS) Device |
| Active Comparator: Pap smear collection using the Rovers Cervex-BrushDiagnostic Test: Use of Rovers Cervex-Brush to collect cervical cells during pap smear collection. | Device | Pap smear collection using the Rovers Cervex-Brush |
Primary outcome
Comparison of the samples for the Predicate Device versus PPS device
Time frame: Baseline
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.
1 secondary outcome
The Comparison of Cell Types of the PPS Device versus the Predicate Device
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Regina K Leonis, MD, MD principal investigator
Morehouse School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pap smear collection using the Personal Pap Smear (PPS) Device and Active Comparator: Pap smear collection using the Rovers Cervex-Brush in people with Cervical Cancer Screening, run by Morehouse School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Regina K Leonis, MD (4047565713, rleonis@msm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the samples for the Predicate Device versus PPS device (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.