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NCT05718193 Clinical Trial

Real-Time Artificial Intelligence Assissted Colonoscopy to Identify and Classify Polyps

Colonoscopy Clinical Trial

Official title:
Real-Time Artificial Intelligence Assissted Colonoscopy to Identify and Classify Polyps

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05718193
Other study ID # 202112254
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2022
Est. completion date March 15, 2023

Study information
Verified date January 2023
Source Xiangya Hospital of Central South University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To investigate the degree of the real-time detection and classification system for increasing the adenoma detection rate during colonoscopy.

Recruitment information / eligibility
Status Completed
Enrollment 2868
Est. completion date March 15, 2023
Est. primary completion date February 28, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: Aged 18 to 85 years old. Colonoscopies for primary CRC screening of the subjects are required. Exclusion Criteria: History of CRC,inflammatory bowel disease, previous colonic resection, antithrombotic therapy precluding polyp resection.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• DeFrame
The DeFrame system is applicated during colonoscopy. The DeFrame system superimposes a rectangular box on the polyp lesion area in the colonoscopy field of view, notifying the endoscopists of the presence of the lesion.
• Classified DeFrame
The Classified DeFrame system is applicated during colonoscopy. The Classified DeFrame system superimposes a rectangular box on the polyp lesion area in the colonoscopy field of view, the color of the rectangle box will turn blue when the polyp is considered as an adenoma, notifying the endoscopists of the presence of the lesion.
• conventional colonoscopy
conventional colonoscopy

Locations
Country Name City State
China Xiangya Hospital Central South University Changsha Hunan
China Loudi Central Hospital Loudi Hunan

Sponsors (2)
Lead Sponsor Collaborator
Xiangya Hospital of Central South University Loudi Central Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary adenoma detection rate Percentage of patients who have 1 or more histologically confirmed adenoma resected divided by the total number of colonoscopies. up to 9 months
Primary adenomas per colonoscopy Total number of histologically confirmed adenomas resected divided by the total number of colonoscopies. up to 9 months
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