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NCT05006092 Clinical Trial

Surveillance Modified by Artificial Intelligence in Endoscopy (SMARTIE)

Artificial Intelligence Clinical Trial

— SMARTIE  

Official title:
Multicenter Evaluation Study of the CADe System ENDOMIND in Surveillance Endoscopy for Colorectal Cancer in German Outpatient Cohort

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05006092
Other study ID # F-2021-047
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2021
Est. completion date November 30, 2022

Study information
Verified date April 2023
Source Wuerzburg University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Evaluation of an artificial intelligence system for polyp detection (CADe)

Description:

We aim to evaluate the artificial intelligence system ENDOMIND that supports endoscopist in detection of polyps during surveillance endoscopy for colorectal cancer. 1070 patients out of 6 gastroenterologic practice are randomized 1:1 for conventional surveillance colonoscopy vs. surveillance with AI support. Primary endpoint is Adenoma detection rate.

Recruitment information / eligibility
Status Completed
Enrollment 1149
Est. completion date November 30, 2022
Est. primary completion date November 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - indication CRC surveillance endoscopy - indication post-polypectomy surveillance endoscopy - positive fecal immunochemical test in patients >=50 years Exclusion Criteria: - reasonable suspicion of inflammatory bowl disease - reasonable suspicion of familiar polyposis Syndrome - Patient after radiation/resection of colonic parts

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• ENDOMIND
CADe system for Polyp detection

Locations
Country Name City State
Germany Universitätsklinikum Würzburg Würzburg Bayern

Sponsors (2)
Lead Sponsor Collaborator
Wuerzburg University Hospital Klinikum Stuttgart

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary adenoma detection rate proportion of individuals undergoing a complete screening colonoscopy who have one or more adenomas 4 months
Secondary polyp detection rate Exmainations with minimum one polyp detected. 4 months
Secondary withdrawal time Time of withdrawal. 4 months
Secondary resection time Time spent on polyp resections. 4 months
Secondary Boston Bowl Preparation Score minimum 0, Maximum 9; should be higher than 5 for appropriate surveillance 4 months
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