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Clinical Trial NCT06120205 for Hpv, HPV 16 Infection, HPV Infection, High Risk HPV is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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SELF-CERV Pivotal Study: SELF-Collection for CERVical Cancer Screening 870 Pivotal Trial

Active, not recruiting
Clinical Trial NCT06120205 is an interventional study for Hpv, HPV 16 Infection, HPV Infection, High Risk HPV that is active, not recruiting. It started on November 20, 2023 with plans to enroll 870 participants. Led by Teal Health, Inc., it is expected to complete by June 1, 2027. The latest data from ClinicalTrials.gov was last updated on July 18, 2025.
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 includ...

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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 colle...

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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

Conditions
HPVHPV 16 InfectionHPV InfectionHigh Risk HPV
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • CLN-TP-020
NCT ID Number
NCT06120205
Start Date (Actual)
2023-11-20
Last Update Posted
2025-07-18
Completion Date (Estimated)
2027-06-01
Enrollment (Estimated)
870
Study Type
Interventional
PHASE
N/A
Status
Active, not recruiting
Keywords
screening
self-collect
HPV
cervical cancer screening
Primary Purpose
Screening
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
OtherSelf-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.
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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
Safety: SAE rate
SAE rate is equivalent for both self-collect and clinician collect interventions
6-14 days following collections
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
25 Years
Eligible Sexes
Female
Accepts Healthy Volunteers
Yes
  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

  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.
Teal Health, Inc. logoTeal Health, Inc.
No contact data.
15 Study Locations in 1 Countries

Alabama

Birmingham OBGYN / Alabama Clinical Therapeutics, Birmingham, Alabama, 35235, United States

California

Planned Parenthood Northern California, San Francisco, California, 94109, United States

Colorado

University of Colorado Anschutz Medical Campus, Aurora, Colorado, 80045, United States

Connecticut

Planned Parenthood Southern New England, New Haven, Connecticut, 06511, United States
Yale University, New Haven, Connecticut, 06520, United States

Louisiana

Woman's Hospital, Baton Rouge, Louisiana, 70817, United States

Maryland

Johns Hopkins University, Baltimore, Maryland, 21287, United States

Massachusetts

Planned Parenthood League of Massachusetts, Boston, Massachusetts, 02215, United States

Missouri

Planned Parenthood St. Louis Region, St Louis, Missouri, 62208, United States
Washington University, St Louis, Missouri, 63110, United States

New York

New York University Langone Hospital, Mineola, New York, 11501, United States

North Carolina

Unified Women's Clinical Research Raleigh, Raleigh, North Carolina, 27607, United States
Unified Women's Clinical Research - Lyndhurst, Winston-Salem, North Carolina, 27103, United States

Texas

Planned Parenthood Gulf Coast, Houston, Texas, 77023, United States

Wisconsin

University of Wisconsin - Madison, Madison, Wisconsin, 53715, United States