Characterization of Colorectal Neoplasia

Colonic Polyp Clinical Trial

— CHANGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04884581
• Other study ID #: CHANGE Study
• Status: Completed
• Phase: N/A
• Start date: May 12, 2021
• Est. completion date: August 5, 2021

Study information

• Verified date: August 2021
• Source: Nuovo Regina Margherita Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: August 5, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonic Polyp
• Colonic Polyps

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Italy	Nuovo Regina Margherita	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Nuovo Regina Margherita Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Post-polypectomy surveillance interval	Agreement in assignment of post-polypectomy surveillance intervals of the enrolled patients according to established guidelines between the combined use of GI Genius CADx as optical diagnosis for diminutive (=5 mm) polyps and conventional histology as diagnostic tool for polyps > 5 mm, and histology as diagnostic tool for all the resected polyps (regardless of size or location)	4 months
Other	Performance metrics of GI Genius CADx	Sensitivity, Specificity, Accuracy, PPV and NPV of GI Genius CADx optical diagnosis	4 months
Other	Performance metrics of the endoscopist with the aid of GI Genius CADx	Sensitivity, Specificity, Accuracy, PPV and NPV of the optical diagnosis of endoscopists assessing lesions in white-light with the help of GI Genius CADx.	4 months
Primary	Negative Predictive Value (NPV)	Negative Predictive Value (NPV) of GI Genius CADx optical diagnosis on diminutive (=5 mm) rectosigmoid polyps	4 months