Development of a Self-collection Device for Cervical Cancer Screening
NCT05669911 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 235
Last updated 2023-11-02
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
Interventions
- 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.
Sponsors & Collaborators
-
Teal Health, Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- SCREENING
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 25 Years
- Max Age
- 65 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-08-28
- Primary Completion
- 2023-11-06
- Completion
- 2023-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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