Characterization of Colorectal Neoplasia (CHANGE)

Nuovo Regina Margherita Hospital

Status: Completed

Conditions: Colonic Polyp

Treatments: Device: GI Genius CADx device

Study type: Interventional

Funder types: Other

Identifiers

NCT04884581

CHANGE Study

Details and patient eligibility

About

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.

Enrollment: 165 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

165 participants in 1 patient group

GI Genius CADx device

Experimental group

Treatment:

Device: GI Genius CADx device