COLOWISE Trial, WV-2022-01, v2.0, 21.11.2022
Research type
Research Study
Full title
REAL TIME COMPUTER AIDED DETECTION OF COLONIC ADENOMAS WITH WISE VISION® ENDOSCOPY: PROSPECTIVE, RANDOMIZED CLINICAL PERFORMANCE EVALUATION
IRAS ID
321888
Contact name
HITOSHI IKEDA
Contact email
Sponsor organisation
NEC Corporation
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 9 months, 19 days
Research summary
Summary of Research
A major challenge in endoscopy is the significant miss rates for abnormalities, including precancerous polyps and cancerous lesions. This is because these abnormalities are difficult to detect and interpret accurately by humans using the naked eye. Researchers using ‘artificial intelligence’ have developed a device called WISE VISION® Endoscopy system which can help the endoscopist to detect polyps, so that less polyps are being “missed”.
This study aims to evaluate whether the computer-aided detection (CADe) device enhances the ability to detect mucosal lesions when compared with the current standard-of-care procedure.
This will be a prospective multi-centre randomized study. Participants will be randomized to receive either standard HDWL colonoscopy (control arm) or colonoscopy with CADe device, WISE VISION® Endoscopy, (experimental arm). All polyps that will be identified during the colonoscopy in both arms will be removed / biopsied as per standard clinical practice.
The CADe device, WISE VISION® Endoscopy, contains an artificial intelligence/machine learning (AI/ML) advanced algorithm to aid the endoscopists in detection of colonic mucosal lesions that will be highlighted to the endoscopists during the real-time colonoscopy procedures.
This study plans to enrol 700 subjects aged ≥ 45 years and < 75 years, who are scheduled for screening or low risk surveillance colonoscopy.
After review of the inclusion and exclusion criteria, eligible subjects will be randomized in a 1:1 ratio to receive either computer-aided colonoscopy (CADe Group) or standard colonoscopy without CADe (Standard Colonoscopy Group).Summary of Results
The COLOWISE pivotal trial results strongly support the WISE VISION® Endoscopy CADe system as an effective tool for preventing colorectal cancer. The study met its key goals, showing a significant improvement in the detection of adenomas (precancerous polyps), increasing detection rates by 0.23.The study also confirmed that using CADe is just as safe as standard procedures, with similar polyp removal rates between the CADe and control groups (47.0% vs. 45.3%, p=0.683). This means the system can be safely integrated into clinical practice without adding risks.
CADe performed well across different patient groups, reasons for procedures, and medical centers, making it a reliable tool for use in various settings, including the U.S. Notably, it was particularly beneficial in patients undergoing surveillance for colorectal cancer and across multiple study sites, regardless of differences in endoscopist experience. These findings suggest that CADe can help improve polyp detection rates, even in settings where physician skill levels vary, ultimately raising the standard of care for both high-risk and general screening patients.
In summary, the WISE VISION® CADe system improves adenoma detection while maintaining the same level of safety as traditional colonoscopy. Its strong and consistent performance across different patient populations, medical centers, and physician experience levels makes it a promising tool for widespread clinical use, enhancing colorectal cancer screening and prevention.
REC name
South East Scotland REC 02
REC reference
23/SS/0011
Date of REC Opinion
1 Mar 2023
REC opinion
Further Information Favourable Opinion