Computer Assisted Quality-monitoring for Magnet-controlled Capsule Endoscopy: a Prospective Case-control Study.

Magnet Controlled Capsule Endoscopy Clinical Trial

Official title:

Computer Assisted Quality-monitoring for Magnet-controlled Capsule Endoscopy: a Prospective Case-control Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04278196
• Other study ID #: 2020SDU-QILU-24
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: May 2021
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

During the past several years，MCE（magnet controlled endoscopy）has made great process in detecting lesions of gastric as well as screening. Compared with conventional endoscopy, magnetically controlled capsule endoscopy can be further optimized in gastric examination. So we make an AI for operators to help improve the quality of MCE and record the mucosa visibilty of gastirc.

Description:

We developed a new artificial intelligence for quality improving during the operation of magnet controlled endoscopy. The AI can help operators screen every part of gastric and then evaluate the visibilty of gastic. Also, It can be record time of the opration. Other than that ,we compared the performancce of AI with experts.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: November 30, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• patients between 18 and75

• patients who can sign informed consent

Exclusion Criteria:

• patients who are unsuitable to accept the check

Related Conditions & MeSH terms

• Magnet Controlled Capsule Endoscopy

Intervention

Other:
• AI-Box
AI-box is a system fixed adjacent to magnet controlled capsule endoscopy. Patients who accept the check of magnet controlled capsule endoscopywill be enrolled .

Locations

Country	Name	City	State
China	Department of Gastroenterology, 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 integrity of the magnet controlled capsule endoscopy	The performance of the operator developing the MCE in screen the gastric without omissions	2 months
Primary	The visibilty of the gastric	Evaluating the performance of AI to recognize the visibility of gastric mucosa	2 months
Primary	The time of operation in gastric	Calculating the time of the magnet controlled capsule endoscapy	2 months