Self-Screening Device for Cervical Cancer

Recruiting in Palo Alto (17 mi)

+6 other locations

Overseen byMegan Fitzpatrick, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Teal Health, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial is testing a new tool that lets women collect their own samples from the cervix and vagina at home. It targets women who need screening for a virus that can cause cervical cancer. The samples are sent to a lab for testing. Self-collection of cervico-vaginal samples for human papillomavirus (HPV) testing has been shown to increase participation in cervical cancer screening among underscreened women.

Eligibility Criteria

This trial is for women aged 25 to 65 with an intact cervix who can consent. It's open to those without current menstruation, not pregnant, and haven't used certain cervical products recently. Women with a history of high-risk HPV or abnormal cytology results are also eligible.

Inclusion Criteria

Group 1: Subject is 25 to 65 years of age and willing to provide informed consent.

Group 1: Subject with intact cervix.

Group 2: Subject is 25 to 65 years of age and willing to provide informed consent.

+2 more

Exclusion Criteria

Subject who reports current menstruation.

Subject is pregnant (based on self-reporting).

Subject has impaired decision-making capacity or unable to provide informed consent.

+4 more

Participant Groups

The study is testing a new self-collection device by Teal Health for cervical cancer screening. Participants will use the device themselves to collect samples that will be evaluated for effectiveness in detecting potential cancer indicators.

1Treatment groups

Experimental Treatment

Group I: Teal Health Self-Collection Device GroupExperimental Treatment1 Intervention

This group will use the Teal Health Self-Collection Device to evaluate the instructions for use, usability, and satisfaction with the self-collection device. Participants will also undergo a Pap smear performed by a clinician. Self-collected and clinician-collected research samples will undergo HPV testing and cytological analysis using tests that are FDA-approved for use for HPV and Pap cytology.