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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04811599
Other study ID # 2020-SDU-QILU-G056
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date March 21, 2021
Est. completion date June 1, 2022

Study information

Verified date March 2021
Source Shandong University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to analysize the relationship between the characteristics of tongue image and the diagnosis of gastrointestinal diseases , then develop and validate a deep learning algorithm for the diagnosis of gastrointestinal diseases depending on tongue images, so as to improve the objectiveness and intelligence of tongue diagnosis. At the same time, gastrointestinal flora of common tongue images were analyzed in order to provide a microecological basis for understanding the relationship between tongue images and digestive tract diseases.


Description:

Tongue diagnosis is an important part of traditional Chinese medicine.According to traditional Chinese medicine theory,health condition can assessed by observing tougue features,including color, gloss, shape and coating of the tongue, tongue features reflect gastric mucosal state, disease classification and prognosis. Recently, deep learning based on central neural networks (CNN) has shownTongue diagnosis is an important part of traditional Chinese medicine.According to traditional Chinese medicine theory,health condition can assessed by observing tougue features,including color, gloss, shape and coating of the tongue, tongue features reflect gastric mucosal state, disease classification and prognosis. Recently, deep learning based on central neural networks (CNN) has shown multiple potential in detecting and diagnosing gastrointestinal diseases. However, there is still a blank in recognition of gastrointestinal diseases .This study aims to develop and validate a deep learning algorithm for the diagnosis of digestive tract diseases depending on tongue images,and analyze gastrointestinal flora of common tongue images.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 2000
Est. completion date June 1, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Patients aged 18 - 80 years undergoing endoscopic examination;patients gave informed consent and signed informed consent. Exclusion Criteria: -

Study Design


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 1 month
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