Development of a Self-collection Device for Cervical Cancer Screening

Pilot Study: Evaluation of a Novel Self-Collection Device for Cervical Cancer Screening

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

Study Overview

• Status: Active, not recruiting
• Conditions: Human Papilloma Virus; Human Papilloma Virus Infection Type 16; Human Papilloma Virus Infection Type 18
• Intervention / Treatment: Device: Teal Health Self-Collection Device Group

Detailed Description

The purpose of this study is to collect design and user input on the safety and effectiveness of the Teal Health self-collection device for patient self-collection of cervicovaginal samples for use with FDA-approved in vitro diagnostics indicated for high risk Human Papillomavirus (hrHPV) screening.

• Study Type: Interventional
• Enrollment (Actual): 235
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Trena Depel; Phone Number: 925-918-0595; Email: trena@tealhealth.co

Study Locations

• United States
  • California
    • Portola Valley, California, United States, 94028
      • Crescendo MD
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70817
      • Woman's Hospital
  • Massachusetts
    • Westwood, Massachusetts, United States, 02090
      • Boston Metro
  • Texas
    • Houston, Texas, United States, 77023
      • Planned Parenthood Gulf Coast
  • Wisconsin
    • Madison, Wisconsin, United States, 53715
      • University of Wisconsin - Madison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Group 1: Inclusion Criteria - General Population Group

1. Subject is 25 to 65 years of age and willing to provide informed consent.
2. Subject with intact cervix.

Group 2: Inclusion Criteria - HPV positive Population Group (HPV+ Enriched Group)

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

Exclusion Criteria:

1. Subject who reports current menstruation.
2. Subject is pregnant (based on self-reporting).
3. Subject has impaired decision-making capacity or unable to provide informed consent.
4. 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.
5. Subject has undergone partial or complete hysterectomy including removal of the cervix.
6. 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.
7. 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Teal Health Self-Collection Device Group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability Survey	Usability Survey data will be analyzed to determine device design issues (There is no scale - questions are assessed individually)	Immediately After Self-collection Procedure
Satisfaction and Needs Survey	Satisfaction and Needs Survey data will be used to assess subjects' general willingness to use an HPV self-collection device, and concerns about HPV self-collection. (There is no scale - questions are assessed individually)	Immediately After Self-collection Procedure
Rate of sample adequacy for liquid-based cytology analysis	Samples will be assessed to determine if there is an adequate number of cells for liquid-based cytology analysis	Up to 30 days

Collaborators and Investigators

• Sponsor: Teal Health, Inc.
• Investigators: Principal Investigator: Megan Fitzpatrick, MD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2022
• Primary Completion (Estimated): November 6, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: November 8, 2022
• First Submitted That Met QC Criteria: December 19, 2022
• First Posted (Actual): January 3, 2023

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: cervical cancer screening; high risk HPV; hrHPV
• Additional Relevant MeSH Terms: Pathologic Processes; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Disease Attributes; DNA Virus Infections; Tumor Virus Infections; Neoplasms, Squamous Cell; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Uterine Cervical Neoplasms; Infections; Communicable Diseases; Virus Diseases; Papillomavirus Infections; Papilloma
• Other Study ID Numbers: TLH-ED-004

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