Evaluation of Gixam's Performance in a FIT Negative Population

Condition(s) studied

Investigational drug(s) / intervention(s)

colorectal cancer (CRC) screening: Gixam test

colorectal cancer screening: Fecal Immunochemistry Test (FIT)

Colonoscopy after bowel cleansing: Standard of care optical colonoscopy for colorectal cancer screening

Study summary

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.

Eligibility

Primary outcome measure(s)

• Safety - number of device related adverse events and serious adverse events — Through study completion, up to 30 days
  Number of device related adverse events and serious adverse events
• Efficacy - Gixam's sensitivity and specificity — 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.

Trial sites (1)

More Jubaan Ltd. trials in the USA

Other trials for the same condition