Characterization of Colorectal Neoplasia

NCT04884581 | Completed

• 1 other identifier: CHANGE Study
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colonic Polyp

Outcome Measures

Primary Outcomes (1)

• Negative Predictive Value (NPV)

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

  4 months

Other Outcomes (3)

• Post-polypectomy surveillance interval

  4 months

• Performance metrics of GI Genius CADx

  4 months

• Performance metrics of the endoscopist with the aid of GI Genius CADx

  4 months

Study Arms (1)

GI Genius CADx device

EXPERIMENTAL

Device: GI Genius CADx device

Interventions

GI Genius CADx device 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.

GI Genius CADx device

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nuovo Regina Margherita Hospital: lead

Study Sites (1)

Nuovo Regina Margherita

Roma, Italy

Location

Related Publications (2)

• Brenner TA, Labaki C, Feuerstein JD, Berzin TM. Prospective Validation of the First US FDA-Approved Computer-Aided Quality Assessment Tool for Colonoscopy: An Initial Clinical Experience. Am J Gastroenterol. 2025 Nov 19. doi: 10.14309/ajg.0000000000003855. Online ahead of print.

  PMID: 41257531 DERIVED

• Hassan C, Balsamo G, Lorenzetti R, Zullo A, Antonelli G. Artificial Intelligence Allows Leaving-In-Situ Colorectal Polyps. Clin Gastroenterol Hepatol. 2022 Nov;20(11):2505-2513.e4. doi: 10.1016/j.cgh.2022.04.045. Epub 2022 Jul 11.

  PMID: 35835342 DERIVED

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 13, 2021
• Study Start: May 12, 2021
• Primary Completion: July 1, 2021
• Study Completion: August 5, 2021
• Last Updated: August 6, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)