Evaluation of Gixam's Performance in a FIT Negative Population

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Device, Procedure
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 85
Healthy Volunteers: f
View:

• Subjects aged 45-85 years.

• Able to provide a signed informed consent.

• Scheduled for a screening colonoscopy at the investigation site.

Locations
United States
Oregon
The Oregon Clinic Gastroenterology-East
RECRUITING
Portland
Contact Information
Primary
Daniella Bleistein
daniella@jubaan.com
+972549599353
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2025-04-30
Participants
Target number of participants: 400
Treatments
Experimental: Single arm
All participants will undergo the same study procedures: FIT, Gixam, and colonoscopy
Sponsors
Leads: Jubaan Ltd.

This content was sourced from clinicaltrials.gov