Non-contact Endoscopy at Covid-19 Outbreak

N/ACompletedNCT04320953

Changhai Hospital5 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Gastrointestinal Disease Infectious Disease

Interventions

Non-contact MCE systemDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Changhai Hospital

Shanghai, China

Outcomes

Primary Outcomes

Technical success

Maneuvarability of the remote control MCE system

Time frame: During the procedure

Secondary Outcomes

Clinical success

Complete observation of the mucosa (\>90% of the mucosa observed) in gastric cardia, fundus, body, angulus, antrum and pylorus

Time frame: During the procedure

Adverse events

Adverse events during and after the procedure

Time frame: During and within 2 weeks after the procedure

Data from ClinicalTrials.gov

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