Non-contact Endoscopy at Covid-19 Outbreak

Study Overview
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Brief Summary
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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
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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.

Official Title
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Non-contact Endoscopy at Covid-19 Outbreak

Conditions
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Gastrointestinal Disease, Infectious Disease

Intervention / Treatment
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* Device: Non-contact MCE system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-contact MCE examination<br>Study subject in this arm receives non-contact MCE examination. | Device: Non-contact MCE system<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | Maneuvarability of the remote control MCE system | During the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical success | Complete observation of the mucosa (>90% of the mucosa observed) in gastric cardia, fundus, body, angulus, antrum and pylorus | During the procedure | 
| Adverse events | Adverse events during and after the procedure | During and within 2 weeks after the procedure |