Pap Smear Collection Methods for Cervical Cancer Screening

Overseen By LaShawn Mays, MSM

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Morehouse School of Medicine

Disqualifiers: Pregnancy, Hysterectomy, Cervical infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two methods for collecting cervical cells during a pap smear, a test used to screen for cervical cancer. Researchers seek to determine if a new device, the Personal Pap Smear™ (PPS) Device, matches the effectiveness of the standard Rovers Cervex-Brush. The trial seeks women aged 21-65 who can read and understand English and do not have certain medical conditions, such as a history of radiation treatment for cervical cancer. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance cervical cancer screening methods.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these pap smear collection methods are safe for cervical cancer screening?

Research shows that both the Personal Pap Smear Device and the Rovers Cervex-Brush are generally easy to use for collecting cervical cell samples.

Less direct safety information exists for the Personal Pap Smear Device. However, similar self-use devices like the Teal Wand have received FDA approval and are known to reduce pain for many users. This suggests that the Personal Pap Smear Device might also be safe and comfortable.

The Rovers Cervex-Brush is well-established and widely used for cervical screenings. Studies have shown it can safely collect cells from different areas of the cervix in one use. It is already included in cervical cancer screening programs.

Overall, both devices appear safe based on current data and experience. However, always consult your healthcare provider for advice specific to your situation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it’s exploring new methods for collecting cervical cell samples, which are crucial for cervical cancer screening. The Personal Pap Smear (PPS) Device is unique because it arrives fully assembled in a sealed bag, making it potentially more convenient and user-friendly. It features a multi-component design with a bristle Collection Brush that is permanently anchored, which might improve the consistency and reliability of the cell collection process. By comparing this with the standard Rovers Cervex-Brush, the trial aims to determine if the PPS Device could be a more efficient or comfortable option for Pap smear collection.

What evidence suggests that these pap smear collection methods are effective for cervical cancer screening?

This trial will compare two methods for Pap smear collection: the Personal Pap Smear (PPS) Device and the Rovers Cervex-Brush. Research shows that the Personal Pap Smear Device can successfully collect cervical cell samples for testing. Earlier studies have proven similar self-collection tools safe and accurate for HPV screening. Specifically, the Teal Wand, another self-collection tool, enabled 98% of participants to gather valid samples. These results suggest that the Personal Pap Smear Device could be a dependable option for cervical cancer screening. Meanwhile, the Rovers Cervex-Brush has effectively collected cervical cells for a long time, with its flexible bristles designed to reach key areas of the cervix. ^{4 6 7 8 9}

Who Is on the Research Team?

Regina K Leonis, MD, MD

Principal Investigator

Morehouse School of Medicine

Are You a Good Fit for This Trial?

This trial is for adult women aged 21-65 who can give informed consent and understand English. It's not suitable for those with conditions affecting their ability to consent or follow the study procedures.

Inclusion Criteria

I can read and understand English.

I am mentally capable of giving my informed consent voluntarily.

I am a woman aged between 21 and 65.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sample Collection

Participants undergo cervical cell sample collection using either the Personal Pap Smear Device™ or the Rovers Cervex-Brush

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after sample collection

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pap smear collection using the Personal Pap Smear (PPS) Device
• Pap smear collection using the Rovers Cervex-Brush

Trial Overview The study compares two methods of collecting cells from the cervix for Pap smears: a self-used device called Personal Pap Smear Device™ and a clinician-assisted tool known as Rovers Cervex-Brush.

How Is the Trial Designed?

Group I: Pap smear collection using the Personal Pap Smear (PPS) Device Experimental Treatment 1 Intervention

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.

Group II: Pap smear collection using the Rovers Cervex-Brush Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Morehouse School of Medicine

Lead Sponsor

Trials

22

Recruited

16,300+

GyneConcepts, Inc.

Collaborator

Trials

1

Recruited

200+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12090030/

Clinical Validation of a Vaginal Cervical Cancer Screening ... This study found that the SC device is a safe and accurate method for primary HPV cervical cancer screening, offering a preferred alternative to ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2211335524001207

Performance of a vaginal self-collection device versus ... This study aims to validate the performance of the vaginal self-sampling device (Vitroveil®) to detect high risk human papillomavirus (hrHPV) in comparison to ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06229275

Comparing Effectiveness of Physician-assisted Versus Self ... 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 ...

4. getteal.com getteal.com/research/u-s-clinical-study-demonstrates-94-of-women-prefer-at-home-cervical-cancer-screening

SELF-CERV clinical trial Our data shows how the Teal Wand can help close the screening gap in the United States, where currently 1 in 4 women are behind on their ...

5. pharmacytimes.com pharmacytimes.com/view/fda-approves-teal-wand-first-at-home-self-collection-cervical-cancer-screening-device

FDA Approves Teal Wand, First At-Home Self-Collection ... Following screening with the Teal Wand, 98% of participants successfully collected a valid sample with the device, and 92% and 39% reported ...

6. getteal.com getteal.com/teal-wand

Teal Wand The first FDA-authorized self-collection device for at-home cervical cancer screening in the US, the Teal Wand is an alternative to the in-person Pap smear ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10676510/

A Comprehensive Review of Cervical Cancer Screening ... This device has successfully visualized 83 % of the overall test patients' cervix while significantly reduced the pain experience by women during the procedure ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2834245

Clinical Validation of a Vaginal Cervical Cancer Screening ... This study found that the SC device is a safe and accurate method for primary HPV cervical cancer screening, offering a preferred alternative to in-clinic ...

9. empr.com empr.com/news/fda-clears-self-collection-device-for-cervical-cancer-screening/

FDA Clears Self-Collection Device for Cervical Cancer ... The FDA has approved the Teal Wand for cervical cancer screening in women at average risk for the disease, aged 25 to 65 years.