Study on the Effectiveness of Gastroscope Operation Quality Control Based on Artificial Intelligence Technology

Gastric Cancer Clinical Trial

Official title:

Study on the Effectiveness of Gastroscope Operation Quality Control Based on Artificial Intelligence Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04384575
• Other study ID #: PX2020047
• Status: Completed
• Start date: February 22, 2020
• Est. completion date: May 1, 2022

Study information

• Verified date: November 2023
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to construct a real-time quality monitoring system based on artificial intelligence technology.

Description:

Gastroscopy plays an important role in the detection and diagnosis of upper gastrointestinal diseases. It is necessary for endoscopists to operate gastroscope according to the standardized process, in order to avoid missing early lesions. However, with the rapid increase in the number of endoscopies, the workload of endoscopists increases further. High workload reduces the quality of endoscopy, resulting in incomplete observation of anatomical parts that are easy to be missed in the process of gastroscopy. There are significant differences in the operation level of different endoscopists. Therefore, carrying out artificial intelligence methods has good academic research and practical value for improving the quality of endoscopic diagnosis and treatment.

Artificial intelligence devices need to use a large number of endoscopic images, based on this, we intends to collect endoscopic image data from our hospitals for training and validation of the model.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1570
• Est. completion date: May 1, 2022
• Est. primary completion date: January 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Patiens aged 18 years or above undergoing gastroscopy;

2. Be able to read, understand and sign informed consent;

Exclusion Criteria:

1. Patients with absolute contraindications to endoscopy examination;

2. pregnant women;

3. previous history of gastric surgery;

4. the researcher considers that the subject is not suitable for clinical trial.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Diagnostic Test:
• blind spots
missed part during map the entire stomach through endoscopy

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Haidian

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy	Calculate the accuracy of AI's judgment on images	2020.2.22-2020.7.1
Primary	Sensitivity	number of images in which AI correctly diagnosed positive/all images with positive	2020.2.22-2020.7.1
Primary	Specificity	number of images in which AI correctly diagnosed negative/all images negative	2020.2.22-2020.7.1