RecruitingNot applicableEN originalColorectal cancer

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

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This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • •Wiek 45-84 lata
  • •Zdolność do wyrażenia świadomej zgody
  • •Ocena lekarza jako pacjent o średnim ryzyku raka jelita grubego
  • •Zaplanowana kolonoskopia przesiewowa w ośrodku badań

✗ Disqualifies

  • •Kolonoskopia przeprowadzona w ostatnich 9 latach
  • •Dodatni wynik testu FIT w ostatnich 11 miesiącach
  • •Historia raka jelita grubego lub polipów dziedzicznych
  • •Rodzinny wywiad raka jelita grubego (bliscy krewni)
  • •Zapalenie jelita grubego (colitis, choroba Crohna)
  • •Antybiotyki lub leki przeciwgrzybiczne w ostatnich 14 dniach przed testem
  • •Wizyta dentystyczna w ciągu 7 dni przed testem Gixam
  • •Piercing w języku

Simplified criteria — AI translation

Trial details

Minimum age
45 Years
Maximum age
84 Years
Last updated (source)
September 21, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (8)

East View Medical Research, LLC

Mobile, United States

Gastro Care Institute

Lancaster, United States

Orlando Gastroenterology, PA

Orlando, United States

Comprehensive Gastrointestinal Health, LLC

Northbrook, United States

Westchester Putnam Gastro

Carmel, United States

NYU Langone Health

New York, United States

Great Lakes Gastroenterology Research, LLC

Mentor, United States

Blue Ridge Medical Research

Lynchburg, United States

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/22/2026.

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