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NCT Number: NCT06612281

Evaluation of Gixam's Performance in a FIT Negative Population

In the United States, colorectal cancer ranks second to lung cancer as a cause of cancer death and is the third most commonly occurring cancer in both men and women. Colorectal cancer in most cases develops slowly over a period of years, starting with the growth of precancerous polyps on the colon or rectum wall. The slow development of colorectal cancer makes it possible to detect and prevent it entirely by the removal of the precancerous polyps with colonoscopy. To date, there is no screening test, other than colonoscopy, able to detect the precancerous polyps. Gixam is a camera that takes multiple pictures of your tongue and uses artificial intelligence software to predict the presence of precancerous polyps within your colon or rectum that may eventually become cancerous.

The device creates the prediction by comparing the images taken of your tongue with many other images of tongues from healthy patients and patients with a history of precancerous polyps. Patients who have been predicted by Gixam to have precancerous polyps may be more likely to complete colonoscopy at the interval recommended by their physician, potentially reducing the likelihood of developing colorectal cancer.

The purpose of this research study is to test the accuracy of the Gixam device in persons that have received a negative outcome on a Fecal Immunochemical Test (FIT). This study will compare this prediction to the actual findings of your scheduled standard care colonoscopy and allow researchers to evaluate and improve the Gixam system.

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Key information

Conditions

Colorectal Adenoma Colonic Diseases Colorectal Cancer (CRC) Colorectal Cancer (CRC) Screening Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Oregon Clinic Gastroenterology-East

Portland, Oregon, 97220, United States

Location status: Recruiting

Location contact

Diane Snelson

CONTACT

[email protected]

503-963-2782

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects aged 45-85 years.
  • Able to provide a signed informed consent.
  • Scheduled for a screening colonoscopy at the investigation site.

Exclusion criteria

  • Undergoing diagnostic colonoscopy for investigation of symptoms.
  • 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.
  • History of colorectal cancer.
  • Family history of colorectal cancer, 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:
  • 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 are 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.
  • Subject has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis and/or Crohn's disease.
  • Subjects with a disability to extend their tongue.
  • Subjects with tongue piercing.
  • Dental visit in the past 7 days prior to Gixam test.
  • Intake of pro-biotics over the past 3 months pre-Gixam test.
  • Subject has any condition that in the opinion of the Investigator should preclude participation in the study.

Treatment and study plan

colorectal cancer (CRC) screening

Device

Gixam test

colorectal cancer screening

Diagnostic Test

Fecal Immunochemistry Test (FIT)

Colonoscopy after bowel cleansing

Procedure

Standard of care optical colonoscopy for colorectal cancer screening

Primary outcomes

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

    Time frame: Through study completion, up to 30 days

    Number of device related adverse events and serious adverse events

  2. Efficacy - Gixam's sensitivity and specificity

    Time frame: Through study completion, up to 30 days

    Gixam's sensitivity and specificity to predict the presence of colorectal adenoma or sessile serrated lesions (advances and non-advanced) / CRC in a FIT negative population.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniella Bleistein

CONTACT

[email protected]

+972549599353

Sponsors and collaborators

Lead sponsor

Jubaan Ltd.

Industry

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 25, 2024
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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