Development of a Self-collection Device for Cervical Cancer Screening

Not Applicable

Active, not recruiting

• Conditions: Human Papilloma Virus Infection Type 16; Human Papilloma Virus; Human Papilloma Virus Infection Type 18
• Interventions: Device: Teal Health Self-Collection Device Group

• Registration Number: NCT05669911
• Lead Sponsor: Teal Health, Inc.

Brief Summary

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

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 Timeline

• Study Start: 2022-08-28
• Study First Submitted: 2022-11-08
• Study First Submitted QC: 2022-12-19
• Study First Posted: 2023-01-03
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-02
• Primary Completion: 2023-11-06
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 235

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Teal Health Self-Collection Device Group	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.

Primary Outcome Measures

Name	Time	Method
Primary Safety: SAEs	Acute - immediately after self-collection procedure	Evaluate SAEs to confirm that SAEs from self-collection are equivalent to the rate of SAEs from health care provider-collection
Primary Effectiveness: Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA)	Up to 30 days	Detection of high risk HPV in self-collected as compared to clinician-collected sample results.
Primary Effectiveness: Sample Inadequacy Rate	Up to 30 days	Sample inadequacy rate defined as percent of high risk HPV DNA concentrations below the detection thresholds as determined by the manufacturer.

Secondary Outcome Measures

Name	Time	Method
Usability Survey	Immediately After Self-collection Procedure	Usability Survey data will be analyzed to determine device design issues (There is no scale - questions are assessed individually)
Satisfaction and Needs Survey	Immediately After Self-collection Procedure	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)
Rate of sample adequacy for liquid-based cytology analysis	Up to 30 days	Samples will be assessed to determine if there is an adequate number of cells for liquid-based cytology analysis

Trial Locations

Locations (6)

University of Wisconsin - Madison; 🇺🇸 Madison, Wisconsin, United States

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States

Planned Parenthood Gulf Coast; 🇺🇸 Houston, Texas, United States

Woman's Hospital; 🇺🇸 Baton Rouge, Louisiana, United States

Crescendo MD; 🇺🇸 Portola Valley, California, United States

Boston Metro; 🇺🇸 Westwood, Massachusetts, United States