Development of a Self-collection Device for Cervical Cancer Screening

NCT05669911 | Active Not Recruiting FDA Device

• 1 other identifier: TLH-ED-004
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 6

Brief Summary

Evaluation of a novel self-collection device for cervical cancer screening.

Conditions

Human Papilloma Virus Infection Type 16; Human Papilloma Virus Infection Type 18; Human Papilloma Virus

Keywords

cervical cancer screening; high risk HPV; hrHPV

Outcome Measures

Primary Outcomes (3)

• Primary Safety: SAEs

  Evaluate SAEs to confirm that SAEs from self-collection are equivalent to the rate of SAEs from health care provider-collection

  Acute - immediately after self-collection procedure

• Primary Effectiveness: Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA)

  Detection of high risk HPV in self-collected as compared to clinician-collected sample results.

  Up to 30 days

• Primary Effectiveness: Sample Inadequacy Rate

  Sample inadequacy rate defined as percent of high risk HPV DNA concentrations below the detection thresholds as determined by the manufacturer.

  Up to 30 days

Secondary Outcomes (3)

• Usability Survey

  Immediately After Self-collection Procedure

• Satisfaction and Needs Survey

  Immediately After Self-collection Procedure

• Rate of sample adequacy for liquid-based cytology analysis

  Up to 30 days

Study Arms (1)

Teal Health Self-Collection Device Group

EXPERIMENTAL

This group will use the Teal Health Self-Collection Device to evaluate the instructions for use, usability, and satisfaction with the self-collection device. Participants will also undergo a Pap smear performed by a clinician. Self-collected and clinician-collected research samples will undergo HPV testing and cytological analysis using tests that are FDA-approved for use for HPV and Pap cytology.

Device: Teal Health Self-Collection Device Group

Interventions

Teal Health Self-Collection Device Group DEVICE

Participants will use the Instructions for Use to perform self-collection of cervicovaginal cells using the Teal Health Self-Collection Device, and will fill out a usability survey and a satisfaction and needs survey. A Pap smear will be performed by a clinician before or after self-collection.

Teal Health Self-Collection Device Group

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is 25 to 65 years of age and willing to provide informed consent.
• Subject with intact cervix.
• Subject is 25 to 65 years of age and willing to provide informed consent.
• Subject with intact cervix.
• Prior diagnosis of high risk HPV and/or positive cytology and/or presenting for colposcopy.

You may not qualify if:

• Subject who reports current menstruation.
• Subject is pregnant (based on self-reporting).
• Subject has impaired decision-making capacity or unable to provide informed consent.
• Subject 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.
• Subject has undergone partial or complete hysterectomy including removal of the cervix.
• Subject has applied any chemical compounds to the cervical area within the 24-hours prior to study sample collection, including iodine, spermicide, douche, anti-fungal medications, generally, and specifically: Replens vaginal moisturizer and RepHresh vaginal hygiene products.
• Subject on whom any form of cervical tissue alteration or surgery has been performed within the prior year, including: conization, Loop electrosurgical excision procedure (LEEP), laser surgery, or cryosurgery.

Sponsors & Collaborators

• Teal Health, Inc.: lead

Study Sites (6)

Crescendo MD

Portola Valley, California, 94028, United States

Location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Woman's Hospital

Baton Rouge, Louisiana, 70817, United States

Location

Boston Metro

Westwood, Massachusetts, 02090, United States

Location

Planned Parenthood Gulf Coast

Houston, Texas, 77023, United States

Location

University of Wisconsin - Madison

Madison, Wisconsin, 53715, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: January 3, 2023
• Study Start: August 28, 2022
• Primary Completion: November 6, 2023
• Study Completion: December 31, 2023
• Last Updated: November 2, 2023

Record last verified: 2023-10

Locations

US (6)