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

HPV Infection Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06120205
• Other study ID #: CLN-TP-020
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: March 2024
• Source: Teal Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 870
• Est. completion date: June 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

Group 1: Inclusion Criteria - General Population Group

1. Participant is 25 to 65 years of age and willing to provide informed consent.

2. Participant has an intact cervix. Group 2: Inclusion Criteria - Enriched Population Group

1. Participant is 25 to 65 years of age and willing to provide informed consent.

2. Participant has an intact cervix.

3. One or more of the below:

• Prior diagnosis of hrHPV within previous 6 months and/or
• Positive cervical Pap cytology result (ASCUS, ASC-H, LSIL, HSIL, SCC, AIS) within previous 6 months and/or
• Presenting for colposcopy/LEEP/excisional intervention Exclusion Criteria - All Groups

1. Participant has impaired decision-making capacity or is unable to provide informed consent.

2. Participant has undergone partial or complete hysterectomy including removal of the cervix.

3. Participant on whom any form of cervical tissue alteration or surgery has been performed within the prior < 5 months, including: conization, loop electrosurgical excision procedure (LEEP), laser ablative surgery, or cryotherapy.

4. Participant is pregnant (based on self-reporting).

5. Participant who reports or is experiencing menstrual bleeding.

6. Participant is participating in another clinical study for an investigational device, drug, or biologic that, in the investigator's opinion, would interfere with the results of this study.

7. Any medical reason that, in the investigator's judgment, would disqualify the participant for a routine pelvic exam with cervical sample collection.

Related Conditions & MeSH terms

• Communicable Diseases
• Hpv
• HPV 16 Infection
• HPV Infection
• Infections
• Papillomavirus Infections
• Uterine Cervical Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado
United States	Johns Hopkins University	Baltimore	Maryland
United States	Woman's Hospital	Baton Rouge	Louisiana
United States	Birmingham OBGYN / Alabama Clinical Therapeutics	Birmingham	Alabama
United States	Planned Parenthood League of Massachusetts	Boston	Massachusetts
United States	Planned Parenthood Gulf Coast	Houston	Texas
United States	University of Wisconsin - Madison	Madison	Wisconsin
United States	New York University Langone Hospital	Mineola	New York
United States	Planned Parenthood Southern New England	New Haven	Connecticut
United States	Yale University	New Haven	Connecticut
United States	Unified Women's Clinical Research Raleigh	Raleigh	North Carolina
United States	Planned Parenthood St. Louis Region	Saint Louis	Missouri
United States	Washington University	Saint Louis	Missouri
United States	Planned Parenthood Northern California	San Francisco	California
United States	Planned Parenthood Arizona	Tucson	Arizona
United States	Unified Women's Clinical Research - Lyndhurst	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Teal Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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