Clinical Efficacy Evaluation of a Computer-aided Colonoscopy as Compared With the Standard Colonoscopy.

Status: Recruiting
Location: See location...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Colonoscopy is clinically used as the gold standard for detection of colorectal cancer (CRC) and removal of adenomatous polyps of the colon and rectum. Evidence has shown that CRC could be prevented by colonoscopic removal of adenomatous polyps. Despite the success of colonoscopy in reducing cancer-related deaths, there exists a disappointing level of adenomas missed at colonoscopy. In recent years, emerging artificial intelligence (AI) and computer-aided detection (CADe) technology has been shown to improve ADR. Based on a meta-analysis, ADR was demonstrated to be significantly higher in the CADe groups than in the standard colonoscopy groups, representing a relative risk of 25.2%. In this study, performance of colonoscopy with or without aid of CADe will be compared in terms of quality indicators. The adenoma detection rate (ADR), which is the proportion of average-risk patients undergoing screening colonoscopy in whom an adenoma is found, is regarded as a robust measure of colonoscopy performance quality that correlates with subsequent cancer risk. Thus, ADR is taken as the primary outcome of this study. The target population includes individuals who are undergoing screening, diagnostic, or surveillance colonoscopy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: t
View:

• Subjects who have given signed informed consent form

• Informed consensus has been obtained that endoscopic resection should be performed if a lesion is found

• Subjects who are scheduled for screening or diagnostic colonoscopy for colorectal cancer (CRC) or surveillance colonoscopy for post-polypectomy follow-up

Locations
Other Locations
Taiwan
National Taiwan University Hospital
RECRUITING
Taipei
Contact Information
Primary
Han-Mo Chiu, MD, PhD
hanmochiu@ntu.edu.tw
+886-2-23123456
Backup
Pei-Chen Lin, MD, MTM, PhD
pclin@aetherai.com
+886-2-27856892
Time Frame
Start Date: 2022-03-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 1500
Treatments
Experimental: Computer-aided colonoscopy
The subject will receive the standard colonoscopy procedure simultaneously with a computer-aided detection (CADe) analysis software designed to automatically detect and highlight potential polyps on colonoscopy images in a real-time manner during colonoscopy procedures.
Active_comparator: Standard colonoscopy
The subject will receive the standard colonoscopy procedure.
Related Therapeutic Areas
Sponsors
Collaborators: Fu Jen Catholic University Hospital, Shin Kong Hospital, Changhua Christian Hospital, aetherAI Co., Ltd
Leads: National Taiwan University Hospital

This content was sourced from clinicaltrials.gov