Non-contact Endoscopy at Covid-19 Outbreak

Not Applicable

Completed

• Conditions: Infectious Disease; Gastrointestinal Disease
• Interventions: Device: Non-contact MCE system

• Registration Number: NCT04320953
• Lead Sponsor: Changhai Hospital

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.

Study Timeline

• Study Start: 2020-03-16
• Study First Submitted: 2020-03-21
• Study First Submitted QC: 2020-03-23
• Study First Posted: 2020-03-25
• Primary Completion: 2020-03-26
• Status Verified: 2020-04
• Study Completion: 2020-04-09
• Last Update Submitted: 2020-04-15
• Last Update Posted: 2020-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Non-contact MCE examination	Non-contact MCE system	Study subject in this arm receives non-contact MCE examination.

Primary Outcome Measures

Name	Time	Method
Technical success	During the procedure	Maneuvarability of the remote control MCE system

Secondary Outcome Measures

Name	Time	Method
Adverse events	During and within 2 weeks after the procedure	Adverse events during and after the procedure
Clinical success	During the procedure	Complete observation of the mucosa (\>90% of the mucosa observed) in gastric cardia, fundus, body, angulus, antrum and pylorus

Trial Locations

Locations (1)

Changhai Hospital; 🇨🇳 Shanghai, China