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

Not Applicable

Active, not recruiting

• Conditions: HPV 16 Infection; HPV Infection; High Risk HPV; Hpv
• Interventions: Device: Teal Wand Self-Collection Device Group

• Registration Number: NCT06120205
• Lead Sponsor: Teal Health, Inc.

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.

Study Timeline

• Study First Submitted: 2023-10-27
• Study First Submitted QC: 2023-11-01
• Study First Posted: 2023-11-07
• Study Start: 2023-11-20
• Primary Completion: 2024-04-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-23
• Last Update Posted: 2025-03-26
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 870

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Self-Collection / Clinician Collection	Teal Wand Self-Collection Device Group	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.

Primary Outcome Measures

Name	Time	Method
Safety: SAE rate	6-14 days following collections	SAE rate is equivalent for both self-collect and clinician collect interventions
Efficacy: Detection of hrHPV in self-collect and clinician collect samples	Samples tested within 7 days of collection	PPA/NPA (Positive Percent Agreement)/(Negative Percent Agreement) of hrHPV detection of self-collected and clinician collected samples

Trial Locations

Locations (15)

Birmingham OBGYN / Alabama Clinical Therapeutics; 🇺🇸 Birmingham, Alabama, United States

Planned Parenthood Northern California; 🇺🇸 San Francisco, California, United States

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States

Planned Parenthood Southern New England; 🇺🇸 New Haven, Connecticut, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

Woman's Hospital; 🇺🇸 Baton Rouge, Louisiana, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Planned Parenthood League of Massachusetts; 🇺🇸 Boston, Massachusetts, United States

Planned Parenthood St. Louis Region; 🇺🇸 Saint Louis, Missouri, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States

New York University Langone Hospital; 🇺🇸 Mineola, New York, United States

Unified Women's Clinical Research Raleigh; 🇺🇸 Raleigh, North Carolina, United States

Unified Women's Clinical Research - Lyndhurst; 🇺🇸 Winston-Salem, North Carolina, United States

Planned Parenthood Gulf Coast; 🇺🇸 Houston, Texas, United States

University of Wisconsin - Madison; 🇺🇸 Madison, Wisconsin, United States