Feasibility of Non-contact Magnetically-controlled Capsule Endoscopy During COVID-19 Pandemic

Study Overview
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Brief Summary
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In December 2019, an outbreak of pneumonia associated with a novel coronavirus named as severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) was reported in Wuhan city, China, and spread exponentially throughout China and other countries in the following weeks. It is recommended that elective endoscopies should be deferred during the COVID-19 outbreak for the potential transmission between patients and medical staff in the statements of Asian Pacific Society for Digestive Endoscopy (APSDE-COVID statements). Therefore, exploring an alternative for patients with the requirements of endoscopy during the outbreak is of great importance. Herein,the investigators developed an novel non-contact magnetically-controlled capsule endoscopy (Nc-MCE) system (Figure 1) adds a remote control workstation and a audio-visual exchange system to the original well-established MCE system. This study was a open-label, prospective, randomized controlled study approved by the institutional review board of Shanghai Changhai Hospital. It was designed to evaluate the diagnostic utility, safety, feasibility and patients acceptability of Nc-MCE in patients with an indication of endoscopy, and comparing it with the result of MCE.

Detailed Description
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The nc-MCE system added a remote control workstation and an audio-visual exchange system to the original well-establish MCE system.Conventional protective measures could be adopted to endoscopist. Although the endoscopist and the patient are in different rooms, the endoscopist was able to see the patient and communicate with him or her through the audio-visual exchange system all the time. In order to simplify the examination procedure, the data recorder was putted on the examination bed. The patient lay down after swallowing the capsule under the remote guidance of the endoscopist.And the endoscopist of MCE and nc-MCE was the same one with experience of more than 1000 cases of MCCG operation. The investigators recruited 40 patients who have related symptom and healthy people mainly from outpatient clinic or hospital health examination center. After fully understanding the procedure of nc-MCE, patients with informed consent were randomly divided into MCE group and nc-MCE group(1:1) by using a stratified block randomization(block size four). The basic characteristics of the enrolled patients were prospectively collected. The primary endpoint was the maneuverability score evaluated by endoscopist. And the investigators choose the gastric examination time,the comfort and acceptability of patients, diagnostic yield and completeness of gastric examination as the secondary endpoint. The safety endpoint of nc-MCE was evaluated by the occurrence of adverse events.

Official Title
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Feasibility of Non-contact Magnetically-controlled Capsule Endoscopy During COVID-19 Pandemic: a Prospective, Open-label, Pilot, Randomized Trial

Conditions
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Gastrointestinal Disease, Infectious Disease, Capsule Endoscopy

Intervention / Treatment
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* Device: non-contact magnetically-controlled capsule endoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed the informed consents before joining this study 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.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The investigators recruited 40 patients who have related symptom and healthy people mainly from outpatient clinic or hostipal health examination center. After fully understanding the procedure of nc-MCE，patients with informed consent were randomly divided into MCE group and nc-MCE group(1:1) by using a stratified block randomization(block size four)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-contact MCE examination<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. In order to simplify the examination procedure, the data recorder was put on the examination bed. The patient lay down after swallowing the capsule under the remote guidance of the endoscopist. | Device: non-contact magnetically-controlled capsule endoscopy<br>* The novel non-contact magnetically-controlled capsule endoscopy (MCE) system (Ankon Technologies, Wuhan, China) (Figure 1) added a remote control workstation and an audio-visual exchange system to the original well-establish MCE system, which consisted of a robotic magnetic arm, a workstation (currently bypassed) and a capsule endoscope.<br>|
| Active Comparator: MCE examination<br>After an overnight fasting and drinking 1000 mL water and simethicone for gastric dilatation and preparation, the subjects put on the data recorder with the help of an endoscopist. Then, the endoscopist activated the capsule with the capsule locator. The patient was instructed to assume the supine or left lateral decubitus position and to swallow the capsule with a small amount of water to effectively observe the esophagus and dentate line. Then, under the guidance of the endoscopist face to face, the subject turned over on the bed to complete the examination. | Device: non-contact magnetically-controlled capsule endoscopy<br>* The novel non-contact magnetically-controlled capsule endoscopy (MCE) system (Ankon Technologies, Wuhan, China) (Figure 1) added a remote control workstation and an audio-visual exchange system to the original well-establish MCE system, which consisted of a robotic magnetic arm, a workstation (currently bypassed) and a capsule endoscope.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Complete Observation | The number of participants with complete observation. Complete observation of the mucosa means over 90% of the mucosa observed in gastric cardia, fundus, body, angulus, antrum and pylorus. | During the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maneuverability Score | 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 and the range of total score from 0 to 20. The higher the score, the better the maneuverability. | During the procedure | 
| Gastric Examination Time(GET) | GET was defined as the time taken for the endoscopist to complete the gastric examination to his or her satisfaction | During the procedure | 
| the Comfort and Acceptability of Patients | The investigators use a satisfaction questionnaire to evaluate the comfort and acceptability of each patient by two sub questionnaires, which was pre-procedure patient perception (3 items, ranged from 0 to 12 ) and post-procedure patient satisfaction (12 items, ranged from 0 to 48) .The higher the score, the worse the patient's satisfaction. | After the procedure(within 5 days) | 
| The Total Number of Patients Who Who Had a Diagnosis of Positive Findings | It was calculated using the following formula: number of patients with positive findings divided by the total number of patients that underwent examination. | after the procedure(within 5 days) |