Detachable String Magnetically Controlled Capsule Endoscopy for Follow-up of Patients With Esophageal Diseases

July 19, 2022 updated by: Zhuan Liao, Changhai Hospital

Accuracy of Detachable String Magnetically Controlled Capsule Endoscopy for Follow-up of Patients With Esophageal Diseases: A Multicenter Study

The purpose of the study is to determine the accuracy of detachable string magnetically controlled capsule endoscopy(DS-MCE) as a follow-up method for patients with previous esophageal diseases.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Esophagogastroduodenoscopy (EGD) is recognized as the gold standard for detection and follow-up of esophageal diseases,allowing for direct mucosal visualization and therapeutic intervention. EGD is however an invasive procedure and there is potential for procedure-related complications, such as perforation and bleeding.Esophageal capsule endoscopy(ECE)provides a novel noninvasive approach to visualize the esophagus.The main drawback for the use of ECE is its unreliable transit time which often renders an inadequate visualization of the esophagus.Thus investigators have developed the detachable string magnetically controlled capsule endoscopy(DS-MCE) which can control the movement of the capsule through the string.

The ds-MCE system consists of two parts: the magnetically controlled capsule endoscopy (MCE) system and a transparent latex sleeve with a hollow string. The magnetically controlled capsule endoscopy (MCE) system (Ankon Technologies, Shanghai, China) detects focal lesions in the stomach with comparable accuracy with conventional EGD. One end of the hollow string is a transparent thin latex sleeve that can be wrapped on the surface of the capsule, and the other end of the string is connected to the syringe. The capsule, which is partially enclosed within the sleeve, can be actively moved in the esophagus through the control of string. In this case, investigator can examine the entire esophageal mucosa several times under real time views. The capsule then could be detached from the string system through injecting air into the hollow string with the syringe after completing the examination of esophagus. The pilot study of ds-MCE confirmed it was a feasible, safe and well-tolerated method for completely viewing esophagus and stomach, without the need for sedation. Besides, the 8-10h battery life of the ds-MCE enables complete examination of the small bowel, which provides the possibility for screening pathological changes in the entire gastrointestinal tract.

This study is a prospective, multi-centered, diagnostic accuracy study. The primary outcome is the diagnostic accuracy of ds-MCE in identifying esophageal diseases. Second outcomes include the visualization and cleanliness of Z-line, safety and patient satisfaction of DS-MCE.

Study Type

Interventional

Enrollment (Anticipated)

310

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, China
      • Shanghai, China
        • Recruiting
        • Zhongshan Hospital
        • Contact:
          • Pinghong Zhou
      • Shanghai, China
      • Shanghai, China
        • Recruiting
        • Shanghai Changhai Hospital
        • Contact:
          • Zhuan Liao
      • Shanghai, China
        • Recruiting
        • Shanghai Sixth People's Hospital
        • Contact:
          • Jinshui Zhu
      • Shanghai, China
        • Recruiting
        • Xuhui District Central Hospital
        • Contact:
          • Yunshi Zhong
      • Shanghai, China
        • Recruiting
        • Yangpu District Central Hospital
        • Contact:

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Gender is not limited.
  2. Patients aged between 18-75 years or older.
  3. Both inpatients and outpatients.
  4. Patients with previous esophageal diseases who are scheduled to undergo EGD for follow-up.
  5. Able to provide informed consent.

Exclusion Criteria:

  1. Patients aged less than 18 years.
  2. Patients with active upper gastrointestinal bleeding.
  3. Patients who have participated in or are participating in other clinical trials within three months.
  4. Patients with cancer on active treatment with chemotherapy and/or radiation therapy.
  5. Pregnancy or suspected pregnancy.
  6. Suspected or known intestinal stenosis or other known risk factors for capsule retention.
  7. Pacemaker or other implanted electromedical devices which could interfere with magnetic resonance.
  8. Patients with dysphagia.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ds-MCE and EGD
All the enrolled participants will undergo the examination of detachable string magnetically controlled capsule endoscopy (ds-MCE) first, followed by EGD within 48 hours.
Diagnostic test: ds-MCE and EGD

Procedure of ds-MCE: The ds-MCE system mainly consists of two parts: the NaviCam magnetic capsule endoscopy guidance system and the detachable string part. The capsule, which is partially enclosed within the sleeve, can be actively moved in the esophagus through the control of string. Investigator can examine the entire esophagus several times under real time views. The capsule then could be detached from the string system through injecting air into the hollow string with the syringe after completing the examination of esophagus. Then, the examination of stomach under magnetic control and small bowel under the natural action of peristalsis follows.

Procedure of EGD: The EGD will be performed using conventional upper gastrointestinal video endoscopy, according to the standard procedure at individual centers. EGD will be performed within 48 hours after ds-MCE procedure and usually during the same endoscopic session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The diagnostic accuracy of the ds-MCE in identifying esophageal diseases in comparison to standardized EGD
Time Frame: 2 weeks
To assess the diagnostic accuracy of the ds-MCE as a follow-up method for patients with previous esophageal diseases, using EGD as the gold standard.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of quadrants visualized at Z-line by ds-MCE
Time Frame: 2 weeks
To assess the visualization of Z-line. Circumferential visualization of the Z line by ds-MCE was defined by quadrants as follows: Z line not observed at all; less than 2 quadrants (< 50 %) of the Z line observed; between 2 quadrants and 3 quadrants (50 % - 75%) observed; more than 3 quadrants (> 75%) observed; and entire Z line (100 %) observed.
2 weeks
Scores of cleanliness of Z-line area
Time Frame: 2 weeks
The effect of bubbles/saliva on the appearance of the Z line area was scored as follows: 0 = no interference by bubbles/saliva on the Z line area; 1 = minor interference of bubbles/saliva on the Z line area; 2 = major interference of bubbles/saliva on the Z line area.
2 weeks
Number of ds-MCE associated adverse events
Time Frame: 2 weeks
To assess the safety of ds-MCE.
2 weeks
The patient satisfaction of the ds-MCE through questionnaires
Time Frame: 2 weeks
To assess the patient satisfaction of the ds-MCE compared to standard EGD.
2 weeks

Collaborators and Investigators

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

Sponsor

Changhai Hospital

Collaborators

Shanghai Zhongshan Hospital
Ruijin Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai 6th People's Hospital
Yangpu District Central Hospital Affiliated to Tongji University
XuHui District Central 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)

July 15, 2019

Primary Completion (Anticipated)

September 15, 2022

Study Completion (Anticipated)

September 15, 2022

Study Registration Dates

First Submitted

July 11, 2022

First Submitted That Met QC Criteria

July 19, 2022

First Posted (Actual)

July 21, 2022

Study Record Updates

Last Update Posted (Actual)

July 21, 2022

Last Update Submitted That Met QC Criteria

July 19, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DS-MCE-esophagus

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

After finishing this study, we will make the data available to other researchers:

including study protocol, statistical analysis plan (SAP), informed consent form (ICF), clinical study report (CSR)

IPD Sharing Time Frame

3 years.

IPD Sharing Access Criteria

The website of the journal where the results published, and ClinicalTrials.gov web site.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

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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