Feasibility of Non-contact Magnetically-controlled Capsule Endoscopy During COVID-19 Pandemic
Condition: Gastrointestinal Disease; Infectious Disease; Capsule Endoscopy
MeSH terms: COVID-19; Communicable Diseases; Infections; Gastrointestinal Diseases; Digestive System Diseases
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): non-contact magnetically-controlled capsule endoscopy
Intervention type(s): Device
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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)
Primary purpose: Prevention