A Real-time Quality Control System of Magnetic-controlled Capsule Gastroscopy

Magnet Controlled Capsule Endoscopy Clinical Trial

Official title:

A Prospective Randomized Controlled Trial of AI-box , a Real-time Quality Control System of Magnetic-controlled Capsule Gastroscopy.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04954677
• Other study ID #: 2021-SDU-QILU-087
• Status: Recruiting
• Phase: N/A
• Start date: August 27, 2021
• Est. completion date: May 2022

Study information

• Verified date: February 2022
• Source: Shandong University
• Contact: Zhen Li, PhD
• Phone: 18560086106
• Email: lizhenh[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

With the rapid development of artificial intelligence technology, more and more deep learning technology has been applied to medicine. Our research is to develop a set of quality control system for magnetic capsule gastroscope using deep learning technology, and conduct a randomized controlled trial to verify its practical efficiency.

Description:

The accuracy of magnetic controlled capsule endoscopy(MCCE) in the diagnosis of stomach lesions is highly consistent with the traditional electronic gastroscopy. It has become a new comfortable and safe form for screening and It is also the beneficial complementarity of the traditional electronic gastroscope. To ensure the medical quality of magnetic controlled capsule endoscopy system, Based on Artificial Intelligence Deep Learning Technology ,investigators developed the Magnetic-controlled Capsule Endoscopic Assisted Quality Control System(AI-box).Randomized controlled trials will be conducted on prospective subjects to verify the quality control efficiency.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Consecutive patients aged 18-75 years old who underwent MCCG examination in Qilu Hospital of Shandong University, Shandong Provincial Hospital affilated to Shandong First Medican University, and the Binzhou Medical University Hospital.

Exclusion Criteria:

• People who are allergic to the ingredients prepared in the stomach before examination;

• Patients with astrointestinal bleeding or ulcers, or prior gastrointestinal bleeding or ulcers within the last 24 months;

• Patients with esophageal and gastric tumor diseases that are undergoing active surgical treatment;

• Contraindications to the MCE test, including suspected or known gastrointestinal obstruction, stenosis, fistula, diverticula, etc; presence of gastrointestinal obstruction symptoms such as pain or dysphagia;

• Prior gastrointestinal tract or abdominal surgery other than simple procedures which would not change the gastrointestinal tract anatomy, such as polyp removal, cholecystectomy or appendectomy;

• Inoperative conditions or refusal to undergo abdominal surgery if required (ie, if the capsule will not pass and cannot be removed by endoscopy);

• A cardiac pacemaker is installed in the body, except when the pacemaker is a new MRE-compatible product;

• Electronic devices such as cochlear implant, magnetic metal drug infusion pump, nerve stimulator and magnetic metal foreign body are implanted in vivo;

• Planned MRI examination before capsule endoscopy discharge;

• Pregnant women;

• Patients with deglutition disorders or gastric emptizing disorders.

Related Conditions & MeSH terms

• Magnet Controlled Capsule Endoscopy

Intervention

Other:
• AI-box
Automatic quality-control system(AI-box)could real-time measure endoscopic inspection completeness, evaluate gastric cleanliness.

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
Shandong University	Ancon Technologies Ltd, Binzhou Medical University, Shandong Provincial Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean inspection completeness	After the inspection,investigators will review the whole process of inspection and record the sites observed as well as unobserved sites,then calculate the inspection completeness(number of observed sites in each patient/10)besides the the blind spot rate(number of unobserved sites in each patient/10 ) per procedure in control group and AI-assisted group.	4 months
Secondary	Cleanliness judgement consistency between expert and AI-box	After the inspection,investigators will review the whole process of inspection and make a judgement of cleanliness of different sites of gastric then compared with the cleanliness judgement of AI-box. So at last investigators will calculate the accuracy of the AI result.	4 months