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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06120205.
To demonstrate that participants who are representative of the intended use population
can understand the Instructions for Use (IFU) and appropriately use the Teal
self-collection device to collect adequate vaginal cells/material for use in primary
hrHPV screening (primary outcome).
To produce sufficient primary hrHPV test results following self-collection, as compared
to the current SoC method of HCP specimen collection, when paired samples are tested
using FDA approved primary hrHPV assays (Roche cobas and/or BD OnClarity).
Primary Effectiveness Objective
• To evaluate the performance of a self-collect device for hrHPV detection as compared to
standard of care (SoC) by:
- Agreement of hrHPV self-collected sample(s) as compared to HCP-collected sample
results.
- Calculating the invalid rate of tested samples.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationTeal Health, Inc.
