Trials / Active Not Recruiting
Active Not RecruitingNCT05669911
Development of a Self-collection Device for Cervical Cancer Screening
Pilot Study: Evaluation of a Novel Self-Collection Device for Cervical Cancer Screening
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 235 (actual)
- Sponsor
- Teal Health, Inc. · Industry
- Sex
- Female
- Age
- 25 Years – 65 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2022-08-28
- Primary completion
- 2023-11-06
- Completion
- 2023-12-31
- First posted
- 2023-01-03
- Last updated
- 2023-11-02
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05669911. Inclusion in this directory is not an endorsement.