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Non-contact Endoscopy at Covid-19 Outbreak

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ClinicalTrials.gov Identifier: NCT04320953
Recruitment Status : Completed
First Posted : March 25, 2020
Last Update Posted : April 17, 2020
Sponsor:
Information provided by (Responsible Party):
Zhuan Liao, Changhai Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Disease Infectious Disease Device: Non-contact MCE system Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Non-contact Endoscopy at Covid-19 Outbreak
Actual Study Start Date : March 16, 2020
Actual Primary Completion Date : March 26, 2020
Actual Study Completion Date : April 9, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arms and Interventions
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Arm Intervention/treatment
Experimental: Non-contact MCE examination
Study subject in this arm receives non-contact MCE examination.
 Device: Non-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.


Outcome Measures
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Primary Outcome Measures :
  1. Technical success [ Time Frame: During the procedure ]
    Maneuvarability of the remote control MCE system


Secondary Outcome Measures :
  1. Clinical success [ Time Frame: During the procedure ]
    Complete observation of the mucosa (>90% of the mucosa observed) in gastric cardia, fundus, body, angulus, antrum and pylorus

  2. Adverse events [ Time Frame: During and within 2 weeks after the procedure ]
    Adverse events during and after the procedure


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04320953


Locations
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China
Changhai Hospital
Shanghai, China, 200433
Sponsors and Collaborators
Changhai Hospital
Investigators
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Principal Investigator: Zhuan Liao, MD Changhai Hospital
More Information
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Publications:

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Responsible Party: Zhuan Liao, Principal Investigator, Changhai Hospital
ClinicalTrials.gov Identifier: NCT04320953    
Other Study ID Numbers: ncMCE1
First Posted: March 25, 2020    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Communicable Diseases
Infection
Gastrointestinal Diseases
Digestive System Diseases