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Status:

ACTIVE_NOT_RECRUITING

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

Lead Sponsor:

Teal Health, Inc.

Conditions:

Hpv

HPV 16 Infection

Eligibility:

FEMALE

25-65 years

Phase:

NA

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...

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 ad...

Eligibility Criteria

Inclusion

  • Group 1: Inclusion Criteria - General Population Group
  • Participant is 25 to 65 years of age and willing to provide informed consent.
  • Participant has an intact cervix.
  • Group 2: Inclusion Criteria - Enriched Population Group
  • Participant is 25 to 65 years of age and willing to provide informed consent.
  • Participant has an intact cervix.
  • 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
  • Participant has impaired decision-making capacity or is unable to provide informed consent.
  • Participant has undergone partial or complete hysterectomy including removal of the cervix.
  • 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.
  • Participant is pregnant (based on self-reporting).
  • Participant who reports or is experiencing menstrual bleeding.
  • 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.
  • Any medical reason that, in the investigator's judgment, would disqualify the participant for a routine pelvic exam with cervical sample collection.

Exclusion

    Key Trial Info

    Start Date :

    November 20 2023

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    June 1 2027

    Estimated Enrollment :

    870 Patients enrolled

    Trial Details

    Trial ID

    NCT06120205

    Start Date

    November 20 2023

    End Date

    June 1 2027

    Last Update

    July 18 2025

    Active Locations (15)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 4 (15 locations)

    1

    Birmingham OBGYN / Alabama Clinical Therapeutics

    Birmingham, Alabama, United States, 35235

    2

    Planned Parenthood Northern California

    San Francisco, California, United States, 94109

    3

    University of Colorado Anschutz Medical Campus

    Aurora, Colorado, United States, 80045

    4

    Planned Parenthood Southern New England

    New Haven, Connecticut, United States, 06511