HPV, HPV - Anogenital Human Papilloma Virus Infection
Conditions
Keywords
hrHPV, cobas HPV test
Brief summary
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).
Detailed description
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.
Interventions
DIAGNOSTIC_TESTMia by XytoTest
Mia by XytoTest is a single-use, sterile, disposable device intended for self-collection of vaginal specimens
DIAGNOSTIC_TESTRovers Cervex-Brush
Rovers Cervex-Brush is for physician collection of vaginal specimens.
Sponsors
Mel Mont Medical
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Intervention model description
Prospective, multi-center, non-randomized, paired-specimen method-comparison study recruiting from a general population and enriched population. Each participant will provide one self-collected vaginal specimen using Mia and one clinician-collected cervical specimen using the Rovers Cervex-Brush.
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Group 1: General Population Group 1. Participants are 25 to 65 years of age and willing to provide informed consent. 2. Participants have an intact cervix. Group 2: Enriched Population Group 1. Participants are 25 to 65 years of age and willing to provide informed consent. 2. Participants have an intact cervix. 3. One or more of: prior diagnosis of hrHPV within previous 6 months; abnormal cervical Pap cytology result of HSIL or higher (HSIL, AIS, or invasive carcinoma per the Bethesda 2014 system) within previous 6 months; and/or presenting for colposcopy/LEEP/excisional intervention.
Exclusion criteria
Apply to all groups: 1. Impaired decision-making capacity or inability to provide informed consent. 2. History of partial or total hysterectomy, including removal of the cervix. 3. Cervical tissue alteration or surgery within 5 months prior (conization, LEEP, laser ablation, or cryotherapy). 4. Current pregnancy (based on self-reporting). 5. Active menstruation at time of specimen collection. 6. Vaginal bleeding within 48 hours. 7. Have had sex or used tampons, creams, or other vaginal products in the last 48 hours. 8. Participation in another clinical study that, in the investigator's opinion, would interfere with the results of this study. 9. Any medical reason that, in the investigator's opinion, would disqualify the participant for a routine pelvic exam with cervical sample collection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of SAEs | Between 6 and 14 days. | Rate of self-collection using Mia as compared to rate of SAEs from clinician-collection. |
| NPA and PPA | Within one week of sample collection. | Concordance between self-collected and physician-collected samples. |
Countries
United States
Contacts
CONTACTLiliana Montes
CONTACTRowena Schokman
Outcome results
None listed