Development of a Self-collection Device for Cervical Cancer Screening

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

235 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-28

Study Completion Date

2023-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Teal Health Self-Collection Device Group

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes