Spots Global Cancer Trial Database for SELF-CERV Pivotal Study: SELF-Collection for CERVical Cancer Screening

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Trial Identification

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

Official Title: SELF-CERV Pivotal Study: Method Comparison of Self-collection Using the Teal Wand Self-Collection Device and HCP (Health Care Provider) Cervical Collection for Detection of High-risk HPV (hrHPV) for Cervical Cancer Screening

Study ID: NCT06120205

Conditions

Interventions

Teal Wand Self-Collection Device Group

Study Description

Brief 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.

Detailed 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.