Not Yet RecruitingNot Applicable

Evaluation of Gixam's Efficacy Predicting Pre-cancerous Colorectal Polyps and Colorectal Cancer

Netherlands800 participantsStarted 2025-02

Plain-language summary

This is a prospective, single arm, multi-center clinical investigation aim to demonstrate the efficacy of Gixam in predicting the presence of premalignant colorectal polyps and colorectal cancer (CRC) in a fecal immunochemical test (FIT) positive population.

Who can participate

Age range50 Years – 80 Years

SexALL

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Inclusion criteria

✓. Subjects aged ≥50 - ≤80 years.
✓. Able to provide a signed informed consent.
✓. Underwent FIT screening within the past 6 months with a positive result.
✓. Scheduled for a FIT positive screening colonoscopy at investigational site.

Exclusion criteria

✕. Has undergone colonoscopy within the past nine (9) years, except for a failed colonoscopy due to poor bowel preparation, which must have been performed within the past year without therapeutic intervention.
✕. Personal history of CRC.
✕. Family history of CRC, defined as having one or more first-degree relatives (parent, sibling, or child) with CRC at any age.
✕. Subject has a diagnosis or medical / family history of any of the following conditions, including:
✕. Subject has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis, and/or Crohn's disease, and/or IBD-undefined.
✕. Subjects with the disability to extend their tongue.
✕. Subjects with tongue piercing.
✕. Dental visit in the 7 days prior to the Gixam test.

What they're measuring

Safety - number of device related adverse events and serious adverse events

Timeframe: Through study completion, up to 30 days

Efficacy - Gixam's sensitivity and specificity

Timeframe: Through study completion, up to 30 days

Trial details

NCT IDNCT06688110

SponsorJubaan Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03

Contact for this trial

Daniella Bleistein

+972549599353 daniella@jubaan.com

View on ClinicalTrials.gov More Colorectal Cancer trials