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

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

Study Overview

• Status: Completed
• Conditions: Artificial Intelligence; Colonoscopy; Quality Control
• Intervention / Treatment: Diagnostic test: DeFrame; Diagnostic test: Classified DeFrame; Diagnostic test: conventional colonoscopy

• Study Type: Interventional
• Enrollment (Actual): 2868
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China
      • Xiangya Hospital Central South University
    • Loudi, Hunan, China
      • Loudi Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The DeFrame Group; Subjects in the DeFrame group were treated with a real-time computer-aided polyp detection system named DeFrame during colonoscopy.	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.
Experimental: The Classified DeFrame Group; Subjects in the Classified DeFrame group were treated with a real-time computer-aided polyp detection and classification system named Classified DeFrame during colonoscopy.	Diagnostic test: 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.
Experimental: The Control Group; Subjects in the control group underwent standard colonoscopy.	Diagnostic test: conventional colonoscopy; conventional colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
adenomas per colonoscopy	Total number of histologically confirmed adenomas resected divided by the total number of colonoscopies.	up to 9 months

Collaborators and Investigators

• Sponsor: Xiangya Hospital of Central South University
• Collaborators: Loudi Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): March 15, 2023

Study Registration Dates

• First Submitted: January 3, 2023
• First Submitted That Met QC Criteria: January 29, 2023
• First Posted (Actual): February 8, 2023

Study Record Updates

• Last Update Posted (Actual): April 11, 2023
• Last Update Submitted That Met QC Criteria: April 9, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 202112254

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No