Evaluation of the Clinical Effectiveness of Upper Gastrointestinal Endoscopy Reporting System

NCT ID: NCT05851885

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-20
• Study Completion Date: 2024-05-20

Brief Summary

The objective of this study is to assess the effectiveness of an AI-based reporting system for upper gastrointestinal endoscopy. The primary question that this study aims to address is whether the reporting system can enhance the completeness and accuracy of endoscopic reports when assisted by AI, as drafted by endoscopists. Patients will be randomly assigned to either the experimental group or the control group. In the experimental group, physicians will draft EGD reports with the assistance of the AI-based reporting system, while in the control group, physicians will use the conventional reporting system to draft EGD reports. At the same time, the AI-based reporting system will automatically generate a report of the EGD examination.

Conditions

Endoscopy, Gastrointestinal; Artificial Intelligence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Experimental group

Physicians draft EGD reports with the assistance of the AI-based reporting system.

Group Type: EXPERIMENTAL

AI-based reporting system

Intervention Type: DIAGNOSTIC_TEST

AI-based reporting system is a software platform for real-time analysis and records of abnormalities and landmarks during endoscopy.

Control group

Physicians use the conventional reporting system to draft EGD reports. At the same time, the AI-based reporting system will automatically generate a report of the EGD examination.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

AI-based reporting system

AI-based reporting system is a software platform for real-time analysis and records of abnormalities and landmarks during endoscopy.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Aged 18 years

2. Aim to undergo screening, surveillance, and diagnosis

3. Undergo sedated EGD

4. Able to read, understand, and sign informed consent

Exclusion Criteria

1. EGD contraindications

2. Not suitable for sedated endoscopy after anaesthesia evaluation

3. Biopsy contraindications

4. Active upper gastrointestinal bleeding or emergency oesophagogastroduodenoscopy (EGD)

5. Pregnancy

6. Upper gastrointestinal surgery or residual stomach

7. Not suitable for recruitment after investigator evaluation because of other high-risk conditions

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Renmin Hospital of Wuhan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Honggang Yu, MD

Role: PRINCIPAL_INVESTIGATOR

Wuhan University Renmin Hospital

Central Contacts

Honggang Yu, MD

Role: CONTACT

yuhonggang1968@163.com

+8613871281899

Other Identifiers

EA-23-007

Identifier Type: -

Identifier Source: org_study_id