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

July 15, 2025 updated by: Teal Health, Inc.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

870

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35235
        • Birmingham OBGYN / Alabama Clinical Therapeutics
    • California
      • San Francisco, California, United States, 94109
        • Planned Parenthood Northern California
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University
      • New Haven, Connecticut, United States, 06511
        • Planned Parenthood Southern New England
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70817
        • Woman's Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Planned Parenthood League of Massachusetts
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University
      • Saint Louis, Missouri, United States, 62208
        • Planned Parenthood St. Louis Region
    • New York
      • Mineola, New York, United States, 11501
        • New York University Langone Hospital
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Unified Women's Clinical Research Raleigh
      • Winston-Salem, North Carolina, United States, 27103
        • Unified Women's Clinical Research - Lyndhurst
    • Texas
      • Houston, Texas, United States, 77023
        • Planned Parenthood Gulf Coast
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
        • University of Wisconsin - Madison

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Self-Collection / Clinician Collection
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.
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.
Other Names:
  • Clinician Collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy: Detection of hrHPV in self-collect and clinician collect samples
Time Frame: 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
Samples tested within 7 days of collection
Safety: SAE rate
Time Frame: 6-14 days following collections
SAE rate is equivalent for both self-collect and clinician collect interventions
6-14 days following collections

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teal Health, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2023

Primary Completion (Actual)

April 5, 2024

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

October 27, 2023

First Submitted That Met QC Criteria

November 1, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Actual)

July 18, 2025

Last Update Submitted That Met QC Criteria

July 15, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLN-TP-020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

De-identified results only

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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