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Evaluation of Gixam's Efficacy Predicting the Presence of Advanced and Non-advanced Colorectal Neoplasia in a FIT Negative Population

28. maj 2026 opdateret af: Jubaan Ltd.

The goal of this clinical trial is to learn if the Gixam device effectively identifies persons with pre-cancer or cancer in the colon and rectum in adults aged 45-84 that are of average risk to develop colorectal cancer and have received a negative result on a Fecal Immunochemical Test (FIT). The main questions it aims to answer are:

  1. Is the Gixam Device effective in identifying persons with pre-cancer or cancer in the colon and rectum that have received a negative FIT result?
  2. Is the use of the Gixam device safe?

Gixam test result will be compared to the findings of a standard of care screening colonoscopy.

Study participants will:

  1. Undergo the Gixam test
  2. Take a FIT at home and ship to a laboratory.
  3. Undergo a standard of care screening colonoscopy.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

1436

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Florida
    • Illinois
      • Northbrook, Illinois, Forenede Stater, 60062
        • Rekruttering
        • Comprehensive Gastrointestinal Health, LLC
        • Kontakt:
    • New York
      • Carmel, New York, Forenede Stater, 10549
        • Rekruttering
        • Westchester Putnam Gastro
        • Kontakt:
    • Ohio
      • Mentor, Ohio, Forenede Stater, 44060
        • Rekruttering
        • Great Lakes Gastroenterology Research, LLC
        • Kontakt:
    • Virginia
      • Lynchburg, Virginia, Forenede Stater, 24502

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

Ingen

Beskrivelse

Inclusion Criteria:

  1. Participants aged ≥45 - ≤84 years.
  2. Able to provide a signed informed consent.
  3. Considered by a physician or healthcare provider as being of 'average risk' for CRC.
  4. Scheduled for a screening colonoscopy at investigation site.

Exclusion Criteria:

  1. Undergoing colonoscopy for investigation of symptoms.
  2. Has undergone colonoscopy within preceding nine (9) years except for a failed colonoscopy due to poor bowel preparation. Failed colonoscopy must have been within the past year and without therapeutic intervention.
  3. Positive FIT or Fecal Occult Blood Test (FOBT) result within the preceding eleven (11) months.
  4. Has completed Cologuard, Sheild, ColoSense or Epi proColon testing within the preceding three (3) years.
  5. History of colorectal cancer.
  6. Family history of colorectal cancer, defined as having one or more first- degree relatives (parent, sibling, or child) with CRC at any age.

  7. Participant has a diagnosis or medical / family history of any of the following conditions, including:

    • Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome)
    • Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome")
    • Other hereditary cancer syndromes including but not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis, or Familial Hyperplastic Polyposis.
  8. Participant has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis and/or Crohn's disease.
  9. Participants with a disability to extend their tongue.
  10. Participants with tongue tremor.
  11. Participants with tongue piercing.
  12. Participants that had a dental visit in the 7 days prior to the Gixam test.
  13. Participants that have taken antibiotics or anti-fungal medications in the 14 days prior to the Gixam test.
  14. Participants that have taken anti-inflammatories or probiotics in the 14 days prior to the Gixam test.
  15. Participant is pregnant.
  16. Participant has any condition that in the opinion of the Investigator should preclude participation in the study.

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention arm
All enrolled participants will undergo the same intervention: Gixam test, FIT, and screening colonoscopy
Enhed: Gixam System
All participant will undergo the Gixam test per device instructions for use
Diagnostisk test: FIT
FIT kit will be handed out to the study participant, who will later sample stool at home and mail the specimen to a reference laboratory for analysis.
Procedure: Standard of care screening colonoscopy
All participants will undergo a standard of care screening colonoscopy which serves as the gold truth in this study

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Primary Safety Endpoint
Tidsramme: From enrollment to the end of study at 30 days after
Number of device-related adverse events and serious adverse events.
From enrollment to the end of study at 30 days after
Primary Efficacy Endpoints
Tidsramme: Through study completion, an average of 30 days
Sensitivity and specificity of Gixam in participants with a negative FIT result.
Through study completion, an average of 30 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Confirmatory Secondary Efficacy Endpoints
Tidsramme: Through study completion, an average of 30 days
Standalone sensitivity and specificity of Gixam in general average risk population.
Through study completion, an average of 30 days

Samarbejdspartnere og efterforskere

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

Sponsor

Jubaan Ltd.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

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)

18. maj 2026

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

31. december 2026

Datoer for studieregistrering

Først indsendt

21. maj 2026

Først indsendt, der opfyldte QC-kriterier

28. maj 2026

Først opslået (Faktiske)

3. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • CL-1009

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 .

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