Computer-aided Detection of Colorectal Polyps

• Conditions: Polyp of Colon; Adenoma Colon
• Interventions: Device: Artificial Intelligence System for Detection of colorectal polyps

• Registration Number: NCT04359355
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

Brief Summary

In this observational pilot study, we assess the diagnostic performance of an artificial intelligence sytem for automated detection of colorectal polyps.

Detailed Description

During standard colonoscopy, a substantial number of colorectal polyps can be missend. As shown in a recent meta-analysis, miss rates for adenomas can reach up to 26%. In this study, it is tested whether an artificial intelligence system that highlights colorectal polyps during screening or surveillance colonoscopy in real time can lead to an increased detection of colorectal polyps during the examination.

Study Timeline

• Study Start: 2020-01-01
• Status Verified: 2020-04
• Study First Submitted: 2020-04-21
• Study First Submitted QC: 2020-04-21
• Last Update Submitted: 2020-04-21
• Study First Posted: 2020-04-24
• Last Update Posted: 2020-04-24
• Primary Completion: 2020-04-30
• Study Completion: 2020-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Screening or surveillance colonoscopy

Exclusion Criteria

• known or suspected inflammatory bowel disease
• uncontrolled coagulopathy
• known polyps or referral for polypectomy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Artificial Intelligence	Artificial Intelligence System for Detection of colorectal polyps	-

Primary Outcome Measures

Name	Time	Method
Feasibility to use the AI System in vivo during colonoscopy	4 month	As a Primary outcome, whether the AI System is capable of detecting colorectal polyps in vivo during colonoscopy

Secondary Outcome Measures

Name	Time	Method
Diagnostic Performance of the AI System for detecting colorectal polyps	4 month	As a secondary outcome, we assess the diagnostic Performance of the AI System for detecing colorectal Polyp in real time

Trial Locations

Locations (1)

University Hospital Erlangen; 🇩🇪 Erlangen, Germany