Characterization of Colorectal Neoplasia

The CHANGE Study: Characterization Helping the Assessment of Colorectal Neoplasia in Gastrointestinal Endoscopy

This is a post-marketing, single-arm, prospective study investigating the use of GI Genius CADx device in the real-time characterization of colorectal polyps (i.e. prediction of their histology during the colonoscopy). Patients enrolled will undergo a standard white-light colonoscopy with the support of the latest version of the CE-marked GI Genius CADx device. Colonoscopy will be performed according to the standard practice.

Inclusion Criteria:

• Patients aged 40 years or older undergoing screening colonoscopy for CRC
• Ability to provide written, informed consent (approved by EC) and understand the responsibilities of trial participation

Exclusion Criteria:

• subjects at high risk for colorectal cancer
• subjects with a personal history of CRC, IBD or hereditary polyposis or non-polyposis syndromes
• patients with previous resection of the sigmoid rectum
• patients on anticoagulant therapy, which precludes resection / removal operations due to histopathological findings
• patients who perform an emergency colonoscopy