Gastrointestinal Disease, Infectious Disease
Conditions
Brief summary
The COVID-19 outbreak and spread throughout the world now constitutes a global public health emergency. Direct contact between doctors and patients in daily practice bears potential risk of Covid-19 infection, and telemedicine, or non-contact medicine, in this circumstance, offers an ideal solution. Remote controlling capsule endoscopy system for gastric examination was recently developed and applicated in clinical practice.
Detailed description
The novel non-contact magnetically-controlled capsule endoscopy (MCE) system (Ankon Technologies, China) adds a remote control workstation and a audio-visual exchange system to the original well-establish MCE system, which consists of a robotic magnetic arm, a workstation (now bypassed) and a capsule endoscope, and boasts a 90% sensitivity and 94% specificity for diagnosing gastric focal lesions. This feasibility study aims to evaluate the technical success, clinical success and adverse events of the first clinical application of non-contact MCE system.
Interventions
DEVICENon-contact MCE system
After an overnight fasting and drinking 1000 mL water and simethicone for gastric dilatation and preparation, the study subject positions himself (herself) on the examination bed in Room A, while the operating doctor sits in Room B at the remote control workstation instructing her to swallow the capsule via the audio-visual exchange system. After the capsule entering the stomach, the doctor manipulated the two joysticks on the remote control workstation, mobilizing the robotic magnetic arm, and simultaneously driving the precise movement and rotation of the capsule to perform the gastric examination.
Sponsors
Changhai Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Signed the informed consents before joining this study
Exclusion criteria
* Dysphagia or symptoms of gastric outlet obstruction, suspected or known intestinal stenosis, history of upper gastrointestinal surgery or abdominal surgery altering gastrointestinal anatomy * Refused abdominal surgery to take out the capsule in case of capsule retention * Implanted pacemaker, except the pacemaker is compatible with MRI * Other implanted electromedical devices or magnetic metal foreign bodies * Pregnancy or suspected pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical success | During the procedure | Maneuvarability of the remote control MCE system |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical success | During the procedure | Complete observation of the mucosa (\>90% of the mucosa observed) in gastric cardia, fundus, body, angulus, antrum and pylorus |
| Adverse events | During and within 2 weeks after the procedure | Adverse events during and after the procedure |
Countries
China
Outcome results
None listed