Characterization of Colorectal Neoplasia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-12

Study Completion Date

2021-08-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Colonic Polyp

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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GI Genius CADx device

Group Type EXPERIMENTAL

GI Genius CADx device

Intervention Type DEVICE

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.

Interventions

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GI Genius CADx device

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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No