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NCT04359355 Clinical Trial

Computer-aided Detection of Colorectal Polyps

Adenoma Colon Clinical Trial

Official title:
Development and Validation of a New Artificial Intelligence System for Automated Detection of Colorectal Polyps During Colonoscopy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04359355
Other study ID # CAID
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date May 31, 2020

Study information
Verified date April 2020
Source University of Erlangen-Nürnberg Medical School
Contact Timo Rath, MD
Phone 49 9131 85
Email timo.rath@uk-erlangen.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date May 31, 2020
Est. primary completion date April 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- Screening or surveillance colonoscopy

Exclusion Criteria:

- known or suspected inflammatory bowel disease

- uncontrolled coagulopathy

- known polyps or referral for polypectomy

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Artificial Intelligence System for Detection of colorectal polyps
In this group, an artificial Intelligence System will be used for computer-aided diagnosis of colorectal polyps. Diagnostic Performance of the artificial intelligence System for detection of polyps will be compared against Operator-based detection in the same group

Locations
Country Name City State
Germany University Hospital Erlangen Erlangen

Sponsors (1)
Lead Sponsor Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Feasibility to use the AI System in vivo during colonoscopy As a Primary outcome, whether the AI System is capable of detecting colorectal polyps in vivo during colonoscopy 4 month
Secondary Diagnostic Performance of the AI System for detecting colorectal polyps As a secondary outcome, we assess the diagnostic Performance of the AI System for detecing colorectal Polyp in real time 4 month
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