Development of a Self-collection Device for Cervical Cancer Screening

Human Papilloma Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05669911
• Other study ID #: TLH-ED-004
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 28, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2023
• Source: Teal Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 235
• Est. completion date: December 31, 2023
• Est. primary completion date: November 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Human Papilloma Virus
• Human Papilloma Virus Infection Type 16
• Human Papilloma Virus Infection Type 18
• Infections
• Papilloma
• Papillomavirus Infections
• Uterine Cervical Neoplasms
• Virus Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado
United States	Woman's Hospital	Baton Rouge	Louisiana
United States	Planned Parenthood Gulf Coast	Houston	Texas
United States	University of Wisconsin - Madison	Madison	Wisconsin
United States	Crescendo MD	Portola Valley	California
United States	Boston Metro	Westwood	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Teal Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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	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
Secondary	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
Secondary	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