The COMBO CAD Study

Artificial Intelligence Clinical Trial

— COMBO-CAd  

Official title:

The COMBO CAD Study: Characterization cOMparison Between twO CAD Systems

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05141409
• Other study ID #: 11
• Status: Completed
• Start date: January 26, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: December 2022
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Implementation of clinical strategies based on optical diagnosis of <5 mm colorectal polyps may lead to a substantial saving of economic and financial resources. Despite this, 84.2% of European endoscopists reported not to use such strategies - also named as leave-in situ and resect- and-discard - in their practice due to the fear of an incorrect optical diagnosis.

Indeed, accuracy of optical diagnosis is operator-dependent, and values reported in the community setting are below the safety thresholds proposed for its incorporation in clinical practice.

Artificial intelligence (AI) is being increasingly explored in different domains of medicine, particularly those entailing image analysis. As optical diagnosis involves subitaneous processing of multiple images, searching for specific visual clues, and recognizing well-defined visual patterns, AI systems has the potential to help endoscopists in distinguish neoplastic from non-neoplastic polyps, making the characterization process more reliable and objective. Computer-Aided-Diagnosis systems aiming at characterization are called CADx.

Preliminary data on CADx showed a high feasibility and accuracy of AI for optical diagnosis of colorectal polyp, and initial experiences in clinical practice confirmed preliminary results.

To assess the potential benefit and risk of AI-assisted optical diagnosis with standard colonoscopy, we exploited two new Computer-Aided-Diagnosis systems (CAD-EYE® Fujifilm Co., and GI-Genius® Medtronic) that provide the endoscopist with a real-time polyp characterization without the need of optical magnification.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• All patients aged 40 or older undergoing a colonoscopy for gastrointestinal symptoms, fecal immunohistochemical test positivity, primary screening or post-polypectomy surveillance

Exclusion Criteria:

• subjects with personal history of CRC, or IBD.

• Subjects affected with Lynch syndrome or Familiar Adenomatous Polyposis.

• patients with inadequate bowel preparation (defined as Boston Bowel Preparation Scale < 2 in any colonic segment).

• patients with previous colonic resection.

• patients on antithrombotic therapy, precluding polyp resection.

• patients who were not able or refused to give informed written consent.

Related Conditions & MeSH terms

• Artificial Intelligence

Intervention

Device:
• Artificial Intelligence
Artificial Intelligence

Locations

Country	Name	City	State
Italy	Department of Gastroenterology, Humanitas Research Hospital	Rozzano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AI-assisted optical diagnosis performance	AI-assisted optical diagnosis performance	6 Months
Secondary	AI alone optical diagnosis performance	AI alone optical diagnosis performance	6 Months