Characterization of Colorectal Neoplasia

Nuovo Regina Margherita Hospital165 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

165

Conditions

Colonic Polyp

Interventions

GI Genius CADx deviceDEVICE

GI Genius System is an Intelligent Endoscopy Module designed to be an adjunct to video colonoscopy with the purpose of supporting the operating physician with artificial intelligence during colonoscopy. GI Genius CADx is the AI software that provides a histology prediction of framed polyps during real-time colonoscopy, with each polyp being classified as adenoma or non-adenoma.

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

Nuovo Regina Margherita

Roma, Italy

Outcomes

Primary Outcomes

Negative Predictive Value (NPV)

Negative Predictive Value (NPV) of GI Genius CADx optical diagnosis on diminutive (≤5 mm) rectosigmoid polyps

Time frame: 4 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.