Gastrointestinal Disease
Conditions
Keywords
capsule endoscopy, magnetically, 5G network, telemedicine
Brief 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.
Interventions
OTHER5G-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.
OTHERMCE examination
The endoscopist (W.Z.) performs the MCE examination procedure conventionally. And communicate with the volunteer face to face in the same examination room.
Sponsors
Changhai Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Gender is not limited. 2. Patients aged 18 years or older. 3. Both inpatients and outpatients. 4. Volunteers with or without abdominal complaints. 5. Able to provide informed consent.
Exclusion criteria
1. dysphagia or symptoms of gastric outlet obstruction, suspected or known intestinal stenosis,overt gastrointestinal bleeding,fistulas and strictures; 2. history of upper gastrointestinal surgery or suspected delayed gastric emptying; 3. Patients with poor general condition,asthma or claus trophobia; 4. Implanted metallic devices such as pacemakers,defibrillators, artificial heart valves or joint prostheses; 5. Pregnancy or mentally ill person; 6. currently participating in another clinical study; 7. communication obstacles persons.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maneuverability score | During the procedure | Maneuverability score was the sum of four subjective scores rated by the operator (signal transmission quality score, operating comfort score, gastric visualization score and study subject compliance score), each of which ranged from 1 to 5 denoting the lowest to the highest degree of satisfaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastric examination time(GET) | During the procedure | GET was defined as the time time taken for the endoscopist to complete the gastric examination to his or her satisfaction. |
| the comfort and acceptability of patients | After the procedure(within 5 days) | The investigators use a satisfaction questionnaire to evaluate the comfort and acceptability of each patient |
| diagnostic yield | after the procedure(within 5 days) | Diagnosis based on the data of 5G-MCE by two endoscopist |
| Adverse events | During and within 2 weeks after the procedure | Adverse events during and after the procedure |
| Clinical success | During the procedure | Complete observation of the mucosa (\>90% of the mucosa observed) in gastric cardia, fundus, body, angulus, antrum and pylorus. |
Countries
China
Outcome results
None listed