Clinical trial NCT04954677: A Real-time Quality Control System of Magnetic-controlled Capsule Gastroscopy
Official title: A Prospective Randomized Controlled Trial of AI-box , a Real-time Quality Control System of Magnetic-controlled Capsule Gastroscopy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Magnet Controlled Capsule Endoscopy
Keywords: Artificial intelligence
Deep learning
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: Ancon Technologies Ltd
name: Shandong Provincial Hospital
name: Binzhou Medical University
First posted: 2021-07-08
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean inspection completeness
timeFrame: 4 months
Secondary outcomes:
measure: Cleanliness judgement consistency between expert and AI-box
timeFrame: 4 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Yanqing Li, PhD
role: STUDY_CHAIR
References: