Comparative Self-collection for Cervical Cancer Screening Pivotal Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-65
SponsorMel Mont Medical
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participants are 25 to 65 years of age and willing to provide informed consent.
Participants have an intact cervix.
Participants are 25 to 65 years of age and willing to provide informed consent.
Participants have an intact cervix.
Disqualifiers
Impaired decision-making capacity or inability to provide informed consent.
History of partial or total hysterectomy, including removal of the cervix.
Cervical tissue alteration or surgery within 5 months prior (conization, LEEP, laser ablation, or cryotherapy).
Current pregnancy (based on self-reporting).
Trial design
Design model
Parallel
Treatments tested in this trial
Mia by XytoTest
Diagnostic testMia by XytoTest is a single-use, sterile, disposable device intended for self-collection of vaginal specimens
Rovers Cervex-Brush
Diagnostic testRovers Cervex-Brush is for physician collection of vaginal specimens.
Treatment groups
260 Participants
are divided into 2 treatment groupsGroup A: General Population GroupActive comparator 2 interventions
Group B: Enriched Population GroupActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
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.2
NPA and PPA
Concordance between self-collected and physician-collected samples.
Time frame
Within one week of sample collection.Sponsors and contacts
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Source ClinicalTrials.gov