Deep Learning Algorithm for the Diagnosis of Gastrointestinal Diseases

Gastrointestinal Disease Clinical Trial

Official title:

Development and Validation of a Deep Learning Algorithm for the Diagnosis of Gastrointestinal Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04222439
• Other study ID #: 2019-SDU-QILU-G710
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: February 2020

Study information

• Verified date: February 2020
• Source: Shandong University
• Contact: Xiuli Zuo, MD,PhD
• Phone: 15588818685
• Email: zuoxiuli[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to develop and validate a deep learning algorithm for the diagnosis of gastrointestinal diseases. Then, evaluate the accuracy this new artificial intelligence(AI) assisted recognition system in clinic practice.

Description:

Recently, deep learning algorithm based on central neural networks (CNN) has shown multiple potential in computer-aided detection and computer-aided diagnose of gastrointestinal lesions. However, there is still a blank in recognition of all gastrointestinal diseases. This study aim to develop and validate a deep learning algorithm for the diagnosis of gastrointestinal diseases. Then, evaluate the accuracy this new artificial intelligence(AI) assisted recognition system in clinic practice.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100000
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants, aged 18 years or older, who had not had a previous endoscopy were retrieved from all participating hospitals.

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Disease
• Gastrointestinal Diseases

Intervention

Device:
• AI for the Diagnosis of Gastrointestinal Diseases
After receiving standard preparation regimen, patients go through colonoscopy or gastroscopy under the AI monitoring device. The whole procedure is monitored by AI associated recognition system. Gastrointestinal diseases will be detect and diagnosis in which the AI device will automatically captured relevant images and report the site of each segment on the screen. Histology analysis is set as a golden standard. Then all the AI captured images will be reviewed by human group, which consists of three to five experienced endoscopic physicians.

Locations

Country	Name	City	State
China	Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The diagnostic accuracy of gastrointestinal diseases with deep learning algorithm.	The diagnostic accuracy of gastrointestinal diseases with deep learning algorithm.	1 month
Secondary	The diagnostic sensitivity of gastrointestinal diseases with deep learning algorithm.	The diagnostic sensitivity of gastrointestinal diseases with deep learning algorithm.	1 month
Secondary	The diagnostic specificity of gastrointestinal diseases with deep learning algorithm.	The diagnostic specificity of gastrointestinal diseases with deep learning algorithm.	1 month
Secondary	The diagnostic positive predictive value of gastrointestinal diseases with deep learning algorithm.	The diagnostic specificity of gastrointestinal diseases with deep learning algorithm.	1 month
Secondary	The diagnostic negative predictive value of gastrointestinal diseases with deep learning algorithm.	The diagnostic specificity of gastrointestinal diseases with deep learning algorithm.	1month