NCT06120205

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 870 (estimated)
• Sponsor: Teal Health, Inc. · Industry
• Sex: Female
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hpv
• HPV 16 Infection
• HPV Infection
• High Risk HPV

Interventions

Type	Name	Description
DEVICE	Teal Wand Self-Collection Device Group	Participants will use the Instructions for Use to perform self-collection of vaginal cells and material using the Teal Wand Self-Collection Device, and will fill out a usability survey and a satisfaction and needs survey. A healthcare provider collected sample will be performed by a clinician after self-collection. The patient will serve as their own comparator/control.

Timeline

• Start date: 2023-11-20
• Primary completion: 2024-04-05
• Completion: 2027-06-01
• First posted: 2023-11-07
• Last updated: 2025-07-18

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated device study