Self-Sampling Device for Cervical Cancer Screening

Recruiting in Palo Alto (17 mi)

+15 other locations

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?

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 HCP (health care provider) cervical collection using primary HPV testing assays. Participants will be asked to use the Teal Wand to provide a self-collected sample prior to a healthcare provider collected sample to be tested for hrHPV. Secondary measure will include usability and preferences.

Eligibility Criteria

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.

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Treatment Details

Interventions

Teal Wand Self-Collection Device (Device)

Trial OverviewThe 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.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Self-Collection / Clinician CollectionExperimental Treatment1 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.