Evaluation of a novel self-collection device for cervical cancer screening.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
235
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.
Crescendo MD
Portola Valley, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Woman's Hospital
Baton Rouge, Louisiana, United States
Boston Metro
Westwood, Massachusetts, United States
Primary Safety: SAEs
Evaluate SAEs to confirm that SAEs from self-collection are equivalent to the rate of SAEs from health care provider-collection
Time frame: Acute - immediately after self-collection procedure
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.
Time frame: Up to 30 days
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.
Time frame: Up to 30 days
Usability Survey
Usability Survey data will be analyzed to determine device design issues (There is no scale - questions are assessed individually)
Time frame: Immediately After Self-collection Procedure
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)
Time frame: Immediately After Self-collection Procedure
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
Time frame: Up to 30 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Planned Parenthood Gulf Coast
Houston, Texas, United States
University of Wisconsin - Madison
Madison, Wisconsin, United States