HPVMIA-COMPNCT07758140
Comparative Self-collection for Cervical Cancer Screening Pivotal Study
A study testing Mia by XytoTest and Rovers Cervex-Brush in people with HPV and HPV - Anogenital Human Papilloma Virus Infection, run by Mel Mont Medical at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV, HPV - Anogenital Human Papilloma Virus Infection
- What is being tested?
- Mia by XytoTest and Rovers Cervex-Brush
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 11 sitesUnited States
- Study dates
- 9 Jul 2026to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Group 1: General Population Group
- Participants are 25 to 65 years of age and willing to provide informed consent.
- Participants have an intact cervix.
- Group 2: Enriched Population Group
- Participants are 25 to 65 years of age and willing to provide informed consent.
- Participants have an intact cervix.
- 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.
Who cannot join
- Apply to all groups:
- 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).
- Active menstruation at time of specimen collection.
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- Vaginal bleeding within 48 hours.
- Have had sex or used tampons, creams, or other vaginal products in the last 48 hours.
- Participation in another clinical study that, in the investigator's opinion, would interfere with the results of this study.
- Any medical reason that, in the investigator's opinion, would disqualify the participant for a routine pelvic exam with cervical sample collection.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
United States11 sites, 11 recruiting
- Recruiting
ASR Idaho CGI
Boise, Idaho, 83702
Stephanie Canning, 208-906-1600, stephaniec@idahoasr.com
- Recruiting
Boeson Research - Great Falls
Great Falls, Montana, 59405
Katie Davis, 406-564-1775, katie@boesonresearch.com
- Recruiting
El Centro de Corazon
Houston, Texas, 77012
Amabely Hernandez, 832-488-8210, ahernandez@clinicagenbio.com
- Recruiting
Altus Clinical Research
Lake Worth, Florida, 33461
Stephanie Feliz, 561-641-0404, sfeliz@altusresearch.com
- Recruiting
National Eagle Research
Lynnwood, Washington, 98036
Samiee Shokati, 206-775-0598, sshokati@nationaleagleresearch.com
- Recruiting
Zenacare Research
North Miami Beach, Florida, 33169
Paola Rothberg, 305-902-3135, paola@zenacare.com
- Recruiting
ASR Arizona CGA
Phoenix, Arizona, 85004
Reena Grewal, 208-906-1600, reena@idahoasr.com
- Recruiting
Unified Women's Clinical Research
Raleigh, North Carolina, 27607
Cassie Harris, 919-788-4449, cassie.harris@unifiedhc.com
- Recruiting
Integrated Clinical Research
Sherman Oaks, California, 91403
Iryna McCormick, 818-861-0088, i.mccormick@icrsite.com
- Recruiting
Innovo-Wilmington Health
Wilmington, North Carolina, 28401
Erin Funk, 910-362-4040, rfunk@wilmingtonhealth.com
- Recruiting
Lyndhurst Clinical Research (Unified)
Winston-Salem, North Carolina, 27103
Amie Butler, 336-765-9350
About this study
Official title: MIA-COMP Pivotal Study: COMParative Self-Collection for Cervical Cancer 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).
Read the 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.
- Being tested
- Mia by XytoTest, Rovers Cervex-Brush
- Keywords
- hrHPV, cobas HPV test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mia by XytoTestDiagnostic test
Mia by XytoTest is a single-use, sterile, disposable device intended for self-collection of vaginal specimens
Rovers Cervex-BrushDiagnostic test
Rovers Cervex-Brush is for physician collection of vaginal specimens.
| Study group | Role | What they receive |
|---|---|---|
| General Population Group | Active comparator | 1. Participants are 25 to 65 years of age and willing to provide informed consent.
2. Participants have an intact cervix. Receives: Diagnostic Test: Mia by XytoTest; Diagnostic Test: Rovers Cervex-Brush |
| Enriched Population Group | Active comparator | 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. Receives: Diagnostic Test: Mia by XytoTest; Diagnostic Test: Rovers Cervex-Brush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of SAEs
Rate of self-collection using Mia as compared to rate of SAEs from clinician-collection.
Measured: Between 6 and 14 days.
NPA and PPA
Concordance between self-collected and physician-collected samples.
Measured: Within one week of sample collection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start9 Jul 2026
- Primary completionAug 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mel Mont Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07758140
- Sponsor's protocol ID
- CLIN-MIA-001
- Acronym
- MIA-COMP
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MIA-COMP Pivotal Study: COMParative Self-Collection for Cervical Cancer Screening
- ClinicalTrials.gov ID
- NCT07758140
- Acronym / sponsor ID
- MIA-COMP / CLIN-MIA-001
- Keywords
- hrHPV, cobas HPV test
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Mel Mont MedicalIndustry (pharma, biotech, devices)
- Study start
- 9 Jul 2026 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| General Population Group | Active comparator | Diagnostic Test: Mia by XytoTest, Diagnostic Test: Rovers Cervex-Brush1. Participants are 25 to 65 years of age and willing to provide informed consent. 2. Participants have an intact cervix. |
| Enriched Population Group | Active comparator | Diagnostic Test: Mia by XytoTest, Diagnostic Test: Rovers Cervex-Brush1. 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. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Group 1: General Population Group
- Participants are 25 to 65 years of age and willing to provide informed consent.
- Participants have an intact cervix.
- Group 2: Enriched Population Group
- Participants are 25 to 65 years of age and willing to provide informed consent.
Key exclusion criteria (10 listed)
- 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).
- Active menstruation at time of specimen collection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mia by XytoTestMia by XytoTest is a single-use, sterile, disposable device intended for self-collection of vaginal specimens | Diagnostic test | Enriched Population Group, General Population Group |
| Rovers Cervex-BrushRovers Cervex-Brush is for physician collection of vaginal specimens. | Diagnostic test | Enriched Population Group, General Population Group |
Primary outcome
Rate of SAEs
Time frame: Between 6 and 14 days.
Rate of self-collection using Mia as compared to rate of SAEs from clinician-collection.
NPA and PPA
Time frame: Within one week of sample collection.
Concordance between self-collected and physician-collected samples.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mia by XytoTest and Rovers Cervex-Brush in people with HPV and HPV - Anogenital Human Papilloma Virus Infection, run by Mel Mont Medical at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liliana Montes (305 335 6162, l.montes@xytotest.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of SAEs (time frame: Between 6 and 14 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.