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Impact of Artificial Intelligence (AI) on Adenoma Detection During Colonoscopy in FIT+ Patients. — AIFIT  

Polyp of Colon Clinical Trial

Official title:
Impact of AI (Artificial Intelligence) on Adenoma Detection During Colonoscopy in FIT+ Patients: a Prospective Randomized Controlled Trial

Clinical Trial Summary

The Italian screening program invites the resident population aged 50-74 for Fecal Immunochemical Test (FIT) every 2 years. Subjects who test positive are referred for colonoscopy. Maximizing adenoma detection during colonoscopy is of paramount importance in the framework of an organized screening program, in which colonoscopy represent the key examination. Initial studies consistently show that Artificial iIntelligence-based systems support the endoscopist in evaluating colonoscopy images potentially increasing the identification of colonic polyps. However, the studies on AI and polyp detection performed so far are mostly focused on technical issues, are based on still images analysis or recorded video segments and includes patients with different indications for colonoscopy. At the best of our knowledge, data on the impact on AI system in adenoma detection in a FIT-based screening program are lacking. The present prospective randomized controlled trial is aimed at evaluating whether the use of an AI system increases the ADR (per patient analysis) and/or the mean number of adenomas per colonoscopy in FIT-positive subjects undergoing screening colonoscopy. Therefore Patients fulfilling the inclusion criteria are randomized (1:1) in two arms: A) patients receive standard colonoscopy (with high definition-HD endoscopes) with white light (WL) in both insertion and withdrawal phase; all polyps identified are removed and sent for histopathology examination; B) patients receive colonoscopy examinations (with HD endoscopes) equipped with an AI system (in both insertion and withdrawal phase); all polyps identified are removed and sent for histopathology examination. In the present study histopathology represents the reference standard.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04691401
Study type Interventional
Source Valduce Hospital
Contact
Status Completed
Phase N/A
Start date December 20, 2020
Completion date December 31, 2021
View Details
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