To evaluate whether individuals drawn from the intended use population can successfully interpret and follow the IFU for the Mia by XytoTest self-collection device and perform a vaginal sample collection yielding sufficient cellular material for primary hrHPV screening. To assess the clinical performance of Mia self-collected vaginal specimens by evaluating agreement with paired clinician-collected cervical specimens for the detection of high-risk HPV, when both specimen types are analyzed using the cobas HPV Test (Roche Molecular Systems). Residual samples may be used to determine adequacy for additional assays that require vaginal and/or cervical specimens (such as mRNA E6 and E7 Biomarker Test, dual stain cytology).
The purpose of this pivotal study is to generate the clinical evidence necessary to support FDA marketing authorization for the Mia device. Specifically, the study will evaluate the diagnostic agreement of Mia-collected self-samples against the standard of care clinician-collected method for primary hrHPV detection, confirm device safety, demonstrate that end users across a diverse population can use the device safely and effectively as directed.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
260
Mia by XytoTest is a single-use, sterile, disposable device intended for self-collection of vaginal specimens
Rovers Cervex-Brush is for physician collection of vaginal specimens.
ASR Arizona CGA
Phoenix, Arizona, United States
RECRUITINGIntegrated Clinical Research
Sherman Oaks, California, United States
RECRUITINGAltus Clinical Research
Lake Worth, Florida, United States
RECRUITINGZenacare Research
North Miami Beach, Florida, United States
RECRUITINGASR Idaho CGI
Boise, Idaho, United States
RECRUITINGBoeson Research - Great Falls
Great Falls, Montana, United States
RECRUITINGUnified Women's Clinical Research
Raleigh, North Carolina, United States
RECRUITINGInnovo-Wilmington Health
Wilmington, North Carolina, United States
RECRUITINGLyndhurst Clinical Research (Unified)
Winston-Salem, North Carolina, United States
RECRUITINGEl Centro de Corazon
Houston, Texas, United States
RECRUITING...and 1 more locations
Rate of SAEs
Rate of self-collection using Mia as compared to rate of SAEs from clinician-collection.
Time frame: Between 6 and 14 days.
NPA and PPA
Concordance between self-collected and physician-collected samples.
Time frame: Within one week of sample collection.
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