Development and Validation of an Artificial Intelligence System for Bowel Preparation Quality Scoring

NCT ID: NCT04487626

Last Updated: 2021-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2020-12-30

Brief Summary

The purpose of this study is to develop and validate the accuracy and reliability of an artificial intelligence(AI) system for bowel preparation quality scoring based of Boston Bowel preparation Scoring(BBPS). Then evaluate whether this AI system can help endoscopists to improve the quality of colonoscopy in clinical practice.

Detailed Description

Bowel preparation is one of the most important factors which decide the quality of colonoscopy. Adequate bowel preparation is essential to guarantee a clear vision of colonic mucosa, complete inspection of entire colon and improves the adenoma detection rates(ADRs). Therefore, the quality of bowel preparation should be evaluated accurately and objectively. However, current bowel preparation quality scales depend on memories and subjective decision of endoscopists. Recently, articifial intelligence system based on deep learning algorithm has been used widely in medical fields. But, few studies have been reported to evaluate the performance of AI system based on deep learning in bowel preparation quality scoring. This study aims to develop and train an AI system to assess bowel preparation quality using the BBPS, and validate the AI system to improve the quality of colonoscopy.

Conditions

Colonic Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Artificial Intelligence assisted Scoring Group

Patients in this group go through colonoscopy under the AI monitoring device.

Group Type: EXPERIMENTAL

AI

Intervention Type: DEVICE

After taking standard bowel preparation regimen, patients receive colonoscopy under the AI system device. During the withdrawal phase, bowel preparation quality is assessed by AI-associated scoring system. The withdrawal time is targeted at least 6min. Every detected polyp will be removed and obtained for pathological assessment.

Interventions

AI

After taking standard bowel preparation regimen, patients receive colonoscopy under the AI system device. During the withdrawal phase, bowel preparation quality is assessed by AI-associated scoring system. The withdrawal time is targeted at least 6min. Every detected polyp will be removed and obtained for pathological assessment.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients aged 20-80 years undergoing elective colonoscopy

Exclusion Criteria

• Patients received colon or rectal surgery

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Center, Korea

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dae Kyung Sohn

Staff surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

NCC2020-0159

Identifier Type: -

Identifier Source: org_study_id