An interventional study of Mia by XytoTest and Rovers Cervex-Brush in HPV and HPV - Anogenital Human Papilloma Virus Infection, sponsored by Mel Mont Medical. Recruiting at 11 sites in United States. Open to female participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Mel Mont Medical · Not applicable, Interventional, and Screening
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.
88 studies on the registry are indexed under Papilloma; 19 are open to participants now.
This study's planned enrollment of 260 is above the median of 119 across 64 interventional studies indexed under Papilloma.
Browse Papilloma studies →This is the only study on the registry with Mel Mont Medical as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Group 1: General Population Group
Group 2: Enriched Population Group
Exclusion Criteria:
Apply to all groups:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1. Participants are 25 to 65 years of age and willing to provide informed consent. 2. Participants have an intact cervix.
Diagnostic Test: Mia by XytoTest · Diagnostic Test: Rovers Cervex-Brush
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.
Diagnostic Test: Mia by XytoTest · Diagnostic Test: Rovers Cervex-Brush
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.
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.
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Aug 2026, 1 month after the start.
Of 28 interventional studies with no phase under Papilloma, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 38. This study's planned 1 month is below that.
How these figures are worked out, and which studies are left out of them.
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