Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Comparative Self-collection for Cervical Cancer Screening Pivotal Study (MIA-COMP)

6. august 2026 opdateret af: Mel Mont Medical

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).

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

260

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85004
        • Rekruttering
        • ASR Arizona CGA
        • Kontakt:
    • California
      • Sherman Oaks, California, Forenede Stater, 91403
        • Rekruttering
        • Integrated Clinical Research
        • Kontakt:
    • Florida
      • Lake Worth, Florida, Forenede Stater, 33461
        • Rekruttering
        • Altus Clinical Research
        • Kontakt:
      • North Miami Beach, Florida, Forenede Stater, 33169
        • Rekruttering
        • Zenacare Research
        • Kontakt:
    • Idaho
      • Boise, Idaho, Forenede Stater, 83702
        • Rekruttering
        • ASR Idaho CGI
        • Kontakt:
    • Montana
      • Great Falls, Montana, Forenede Stater, 59405
        • Rekruttering
        • Boeson Research - Great Falls
        • Kontakt:
    • North Carolina
      • Raleigh, North Carolina, Forenede Stater, 27607
        • Rekruttering
        • Unified Women's Clinical Research
        • Kontakt:
      • Wilmington, North Carolina, Forenede Stater, 28401
      • Winston-Salem, North Carolina, Forenede Stater, 27103
        • Rekruttering
        • Lyndhurst Clinical Research (Unified)
        • Kontakt:
          • Amie Butler
          • Telefonnummer: 336-765-9350
    • Texas
      • Houston, Texas, Forenede Stater, 77012
    • Washington
      • Lynnwood, Washington, Forenede Stater, 98036

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Screening
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: General Population Group
  1. Participants are 25 to 65 years of age and willing to provide informed consent.
  2. Participants have an intact cervix.
Diagnostisk test: Mia by XytoTest
Mia by XytoTest is a single-use, sterile, disposable device intended for self-collection of vaginal specimens
Diagnostisk test: Rovers Cervex-Brush
Rovers Cervex-Brush is for physician collection of vaginal specimens.
Aktiv komparator: 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.
Diagnostisk test: Mia by XytoTest
Mia by XytoTest is a single-use, sterile, disposable device intended for self-collection of vaginal specimens
Diagnostisk test: Rovers Cervex-Brush
Rovers Cervex-Brush is for physician collection of vaginal specimens.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Rate of SAEs
Tidsramme: Between 6 and 14 days.
Rate of self-collection using Mia as compared to rate of SAEs from clinician-collection.
Between 6 and 14 days.
NPA and PPA
Tidsramme: Within one week of sample collection.
Concordance between self-collected and physician-collected samples.
Within one week of sample collection.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Mel Mont Medical

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

9. juli 2026

Primær færdiggørelse (Anslået)

1. august 2026

Studieafslutning (Anslået)

1. september 2026

Datoer for studieregistrering

Først indsendt

6. august 2026

Først indsendt, der opfyldte QC-kriterier

6. august 2026

Først opslået (Faktiske)

11. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • CLIN-MIA-001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner