SELF-CERV Pivotal Study: SELF-Collection for CERVical Cancer Screening

Status Enrolling by invitation

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06120205
Study type	Interventional
Source	Teal Health, Inc.
Contact
Status	Enrolling by invitation
Phase	N/A
Start date	November 15, 2023
Completion date	June 1, 2024

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