NCT04670692

Feasibility of Remote MCE for Upper GI Tract Examination Under Five-generation Network

Feasibility of Remote Magnetically Controlled Capsule Endoscopy for Upper Gastrointestinal Tract Examination Under Five-generation Network: a Prospective, Open-label, Pilot Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

With the combination of robotic and 5G network communication technology, telemedicine becomes more and more feasible and efficient. Magnetically controlled capsule endoscopy (MCE) has been confirmed to have comparable accuracy with conventional gastroscopy with the advantages of comfort and convenience. 5G communication technology has been applied to several fields in telemedicine, but its effectiveness, safety, and stability in remote magnetically controlled capsule endoscopy for upper gastrointestinal tract examination have not been established. The aim of this study is to evaluate the diagnostic utility, safety, feasibility and patient's acceptability of remote magnetically controlled capsule endoscopy system under 5G network.

Detailed description

With the combination of robotic and 5G network communication technology, telemedicine becomes more and more feasible and efficient. On the one hand, telemedicine can conserve and optimize medical resources, providing high-quality medical services to unbalanced areas, such as rural areas, stricken areas and battlefields. On the other hand, telemedicine can reduce the time spent by patients waiting for examination and treatment and thus prevent diseases from worsening. Magnetically controlled capsule endoscopy (MCE) has been confirmed to have comparable accuracy with conventional gastroscopy with the advantages of comfort and convenience. 5G communication technology has been applied to several fields in telemedicine, but its effectiveness, safety, and stability in remote magnetically controlled capsule endoscopy for upper gastrointestinal tract examination have not been established. The 5G-MCE system was provided by Ankon Technologies Co, Ltd (Shanghai, China), this system consists of three parts: remote console, remote control software (NaviRemoteCtrl), and remote connection software (NaviRemoteConn). The remote console (based in Shanghai), takes the endoscopist's input and translates it into a control signal. After network transmission, the patient side cart (based in Yinchuan) translates the control signal into actual instrument manipulation. The images captured by the capsule are simultaneously sent back to the screen of the remote console, and thus provide guidance for better control of the capsule. The aim of this study is to evaluate the diagnostic utility, safety, feasibility and patient's acceptability of remote magnetically controlled capsule endoscopy system under 5G network.

Conditions

• Gastrointestinal Disease

Interventions

Type	Name	Description
OTHER	5G-MCE examination	The endoscopist (W.Z.) manipulated the two joysticks on the remote console (based in Shanghai). Then the remote control software and remote connection software takes the endoscopist's input and translates it into a control signal. After network transmission, the patient side cart (based in Yinchuan) translates the control signal into actual instrument manipulation and mobilize the robotic magnetic arm, and simultaneously driving the precise movement and rotation of the capsule to perform the gastric and duodenum examination. Meanwhile, the images captured by the capsule are simultaneously sent back to the screen of the remote console, and thus provide guidance for better control of the capsule.
OTHER	MCE examination	The endoscopist (W.Z.) performs the MCE examination procedure conventionally. And communicate with the volunteer face to face in the same examination room.

Timeline

• Start date: 2020-12-30
• Primary completion: 2021-05-30
• Completion: 2021-07-30
• First posted: 2020-12-17
• Last updated: 2021-09-24

Locations

1 site across 1 country: China