Feasibility of Remote MCE for Upper GI Tract Examination Under Five-generation Network

September 18, 2021 updated by: Zhuan Liao, Changhai Hospital

Feasibility of Remote Magnetically Controlled Capsule Endoscopy for Upper Gastrointestinal Tract Examination Under Five-generation Network: a Prospective, Open-label, Pilot Trial

With the combination of robotic and 5G network communication technology, telemedicine becomes more and more feasible and efficient. Magnetically controlled capsule endoscopy (MCE) has been confirmed to have comparable accuracy with conventional gastroscopy with the advantages of comfort and convenience. 5G communication technology has been applied to several fields in telemedicine, but its effectiveness, safety, and stability in remote magnetically controlled capsule endoscopy for upper gastrointestinal tract examination have not been established. The aim of this study is to evaluate the diagnostic utility, safety, feasibility and patient's acceptability of remote magnetically controlled capsule endoscopy system under 5G network.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

With the combination of robotic and 5G network communication technology, telemedicine becomes more and more feasible and efficient. On the one hand, telemedicine can conserve and optimize medical resources, providing high-quality medical services to unbalanced areas, such as rural areas, stricken areas and battlefields. On the other hand, telemedicine can reduce the time spent by patients waiting for examination and treatment and thus prevent diseases from worsening.

Magnetically controlled capsule endoscopy (MCE) has been confirmed to have comparable accuracy with conventional gastroscopy with the advantages of comfort and convenience. 5G communication technology has been applied to several fields in telemedicine, but its effectiveness, safety, and stability in remote magnetically controlled capsule endoscopy for upper gastrointestinal tract examination have not been established.

The 5G-MCE system was provided by Ankon Technologies Co, Ltd (Shanghai, China), this system consists of three parts: remote console, remote control software (NaviRemoteCtrl), and remote connection software (NaviRemoteConn). The remote console (based in Shanghai), takes the endoscopist's input and translates it into a control signal. After network transmission, the patient side cart (based in Yinchuan) translates the control signal into actual instrument manipulation. The images captured by the capsule are simultaneously sent back to the screen of the remote console, and thus provide guidance for better control of the capsule.

The aim of this study is to evaluate the diagnostic utility, safety, feasibility and patient's acceptability of remote magnetically controlled capsule endoscopy system under 5G network.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Changhai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Gender is not limited.
  2. Patients aged 18 years or older.
  3. Both inpatients and outpatients.
  4. Volunteers with or without abdominal complaints.
  5. Able to provide informed consent.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 5G-MCE examination
There will be 20 volunteers assigned to the 5G-MCE system group. These patients will accept the magnetically controlled capsule examination in Yinchuan. After an overnight fasting and drinking 800-1000 mL water and simethicone for gastric dilatation and preparation, the subjects put on the data recorder with the help of the assistant in Yinchuan. Then, the assistant activated the capsule with the capsule locator. The patient is instructed to swallow the capsule with a small amount of water to effectively observe the esophagus and dentate line. After the capsule entering into the stomach, the examination will be performed through the 5G-MCE system by the endoscopist (W.Z.), with experience of more than 1000 cases of MCE operation, in Shanghai.
Other: 5G-MCE examination
The endoscopist (W.Z.) manipulated the two joysticks on the remote console (based in Shanghai). Then the remote control software and remote connection software takes the endoscopist's input and translates it into a control signal. After network transmission, the patient side cart (based in Yinchuan) translates the control signal into actual instrument manipulation and mobilize the robotic magnetic arm, and simultaneously driving the precise movement and rotation of the capsule to perform the gastric and duodenum examination. Meanwhile, the images captured by the capsule are simultaneously sent back to the screen of the remote console, and thus provide guidance for better control of the capsule.
Active Comparator: MCE examination
There will be 20 volunteers assigned to the MCE system group as comparator group. After an overnight fasting and drinking 800-1000 mL water and simethicone for gastric dilatation and preparation, the subjects put on the data recorder with the help of the endoscopist. Then, the endoscopist activated the capsule with the capsule locator. The patient is instructed to assume the 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 (W.Z.) face to face, subject continue the examination of stomach and duodenum.
Other: MCE examination
The endoscopist (W.Z.) performs the MCE examination procedure conventionally. And communicate with the volunteer face to face in the same examination room.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maneuverability score
Time Frame: During the procedure
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.
During the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric examination time(GET)
Time Frame: During the procedure
GET was defined as the time time taken for the endoscopist to complete the gastric examination to his or her satisfaction.
During the procedure
the comfort and acceptability of patients
Time Frame: After the procedure(within 5 days)
The investigators use a satisfaction questionnaire to evaluate the comfort and acceptability of each patient
After the procedure(within 5 days)
diagnostic yield
Time Frame: after the procedure(within 5 days)
Diagnosis based on the data of 5G-MCE by two endoscopist
after the procedure(within 5 days)
Adverse events
Time Frame: During and within 2 weeks after the procedure
Adverse events during and after the procedure
During and within 2 weeks after the procedure
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.
During the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 30, 2020

Primary Completion (Actual)

May 30, 2021

Study Completion (Actual)

July 30, 2021

Study Registration Dates

First Submitted

December 11, 2020

First Submitted That Met QC Criteria

December 11, 2020

First Posted (Actual)

December 17, 2020

Study Record Updates

Last Update Posted (Actual)

September 24, 2021

Last Update Submitted That Met QC Criteria

September 18, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5G-MCE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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