Self-Sampling Device for Cervical Cancer Screening

Not currently recruiting at 17 trial locations

Overseen By Courtney Parsons

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Teal Health, Inc.

Disqualifiers: Hysterectomy, Cervical surgery, Pregnancy, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of a new self-sampling device, the Teal Wand, for detecting high-risk HPV, a virus linked to cervical cancer. It compares results from using this device at home to those from samples taken by healthcare professionals. The study also evaluates the device's ease of use and gathers participant feedback. Women with an intact cervix who have recently tested positive for HPV or had abnormal cervical screening results may be suitable candidates. As an unphased trial, this study provides participants the opportunity to contribute to research that could make cervical cancer screening more accessible and convenient.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinator or your doctor.

What prior data suggests that the Teal Wand Self-Collection device is safe for cervical cancer screening?

Research has shown that the Teal Wand Self-Collection Device is safe for cervical cancer screening. The FDA has approved the device, confirming it meets safety standards for detecting high-risk HPV, a virus linked to cervical cancer. Studies have found that the Teal Wand reliably and accurately collects samples for testing.

Many users prefer this device, noting its comfort. Although detailed information on side effects is lacking, its FDA approval and positive user feedback reassure its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Teal Wand Self-Collection Device because it offers a new way for cervical cancer screening that empowers patients to collect samples themselves. Unlike the standard clinician-collected Pap smear, this device allows for a more private and potentially more comfortable experience, which might increase screening rates among women who are hesitant to undergo traditional methods. Additionally, by enabling self-sampling, it could improve access to screening for those in remote areas or with limited access to healthcare facilities. This method comparison study aims to find out if the Teal Wand is as effective as the clinician collection process, potentially offering a game-changing alternative for cervical cancer detection.

What evidence suggests that the Teal Wand Self-Collection Device is effective for cervical cancer screening?

Research shows that the Teal Wand Self-Collection Device effectively detects high-risk HPV, a virus linked to cervical cancer. In one study, the Teal Wand matched results from doctor-collected tests 95% of the time. In this trial, participants will use the Teal Wand Self-Collection Device and also undergo clinician collection to compare the methods. The SELF-CERV study found that many women prefer using this at-home test over visiting a clinic. The Teal Wand could assist those who are behind on their cervical cancer screenings. ^{4 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for women aged 25-65 with an intact cervix, who can consent to participate. It includes those previously diagnosed with high-risk HPV or abnormal Pap results within the last 6 months, and those undergoing certain cervical procedures.

Inclusion Criteria

Group 2: Inclusion Criteria - Enriched Population Group

I have an intact cervix.

I am between 25 and 65 years old and agree to participate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Self-Collection and Clinician Collection

Participants use the Teal Wand for self-collection followed by a healthcare provider collection for hrHPV testing

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after sample collection

2 weeks

1 follow-up contact (virtual or phone)

What Are the Treatments Tested in This Trial?

Interventions

• Teal Wand Self-Collection Device

Trial Overview The study compares the effectiveness of a self-collection device called Teal Wand for detecting high-risk HPV (hrHPV) against samples collected by healthcare providers using standard HPV testing methods.

How Is the Trial Designed?

Group I: Self-Collection / Clinician Collection Experimental Treatment 1 Intervention

Patient serves as own comparator/control in this method comparison study where the investigational intervention is use of the self-collect device and the comparator is the standard of care clinician collection.

Who Is Running the Clinical Trial?

Teal Health, Inc.

Lead Sponsor

Trials

2

Recruited

1,100+

Published Research Related to This Trial

Cervicovaginal self-sampling using the Evalyn Brush for hr-HPV testing showed a 97.5% agreement with physician-collected samples, indicating it is a reliable method for detecting high-risk HPV.

The self-sampling method identified hr-HPV in 93.5% of patients with cervical intraepithelial neoplasia grade 3 or worse, demonstrating its effectiveness in identifying significant cervical disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Excellent analytical and clinical performance of a dry self-sampling device for human papillomavirus detection in an urban Chinese referral population. Chen, K., Ouyang, Y., Hillemanns, P., et al.[2017]

Self-collected cervicovaginal lavage for HPV testing showed high concordance (93%) with results from traditional cervical smears, indicating it could be a reliable alternative for cervical cancer screening.

While 88% of women found the self-sampling device acceptable, the concordance for cytology results was lower (54% with doctor and 41% with patient), suggesting that self-sampling is more effective for HPV testing than for cytology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary screening for high risk HPV by home obtained cervicovaginal lavage is an alternative screening tool for unscreened women. Nobbenhuis, MA., Helmerhorst, TJ., van den Brule, AJ., et al.[2022]

A study involving 822 women in South Africa found that most participants had a positive attitude towards self-sampling for cervical cancer screening, with 93.6% not feeling embarrassed and 89.4% reporting no discomfort during the process.

Despite their positive perceptions, 64.7% of women felt more confident when samples were taken by clinicians, mainly due to concerns about the quality of self-collected samples and the financial burden of returning to the clinic with the sample.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

South African women's perspectives on self-sampling for cervical cancer screening: A mixed-methods study. Saidu, R., Moodley, J., Tergas, A., et al.[2019]

Citations

1. 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 ...

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

Clinical Validation of a Vaginal Cervical Cancer Screening ... This nonrandomized clinical trial assesses the clinical validity, accuracy, and safety of a self-collection method for cervical cancer ...

3. getteal.com getteal.com/news/teal-health-announces-publication-of-self-cerv-study-results-in-jama-network-open-following-fda-approval-of-teal-wand-tm-for-at-home-hpv-screening

Teal Health Announces Publication of SELF-CERV Study ... Key study results showed that the Teal Wand was highly effective for sample collection with a 95% positive agreement for detection of high-risk HPV.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06120205?term=teal%20health&rank=1

SELF-CERV Pivotal Study: SELF-Collection for CERVical ... The goal of this method comparison study is to compare the detection of hrHPV collected using the Teal Wand Self-Collection device to hrHPV detected from ...

5. getteal.com getteal.com/news/teal-health-unveils-landmark-study-results-showing-teal-wand-self-collected-samples-match-clinician-collected-samples

Teal Health Unveils Landmark Study Results Showing ... SELF-CERV study validates the Teal Wand at-home cervical cancer screening as a preferred and viable alternative to in-person screening.

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/DEN240045.pdf

DEN240045 - accessdata.fda.gov The benefit of the Teal Wand is that individuals can self-collect vaginal specimens for the detection of clinically significant infection with high-risk (HR) ...

7. getteal.com getteal.com/teal-wand

Teal Wand The Teal Wand is a self-collection device in which the collected sample is mailed to a lab to test for high-risk HPV using an FDA-approved Primary HPV test.

8. getteal.com getteal.com/teal-wand-package-insert

Teal Wand™ Package Insert Vaginal samples collected with Teal Wand are intended for primary HPV cervical cancer screening on FDA approved HPV molecular assays, but do not substitute for ...