Feasibility of Non-contact Magnetically-controlled Capsule Endoscopy During COVID-19 Pandemic

NCT04389333 | Completed Results

• 1 other identifier: nc-MCE pilotRCT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In December 2019, an outbreak of pneumonia associated with a novel coronavirus named as severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) was reported in Wuhan city, China, and spread exponentially throughout China and other countries in the following weeks. It is recommended that elective endoscopies should be deferred during the COVID-19 outbreak for the potential transmission between patients and medical staff in the statements of Asian Pacific Society for Digestive Endoscopy (APSDE-COVID statements). Therefore, exploring an alternative for patients with the requirements of endoscopy during the outbreak is of great importance. Herein,the investigators developed an novel non-contact magnetically-controlled capsule endoscopy (Nc-MCE) system (Figure 1) adds a remote control workstation and a audio-visual exchange system to the original well-established MCE system. This study was a open-label, prospective, randomized controlled study approved by the institutional review board of Shanghai Changhai Hospital. It was designed to evaluate the diagnostic utility, safety, feasibility and patients acceptability of Nc-MCE in patients with an indication of endoscopy, and comparing it with the result of MCE.

Conditions

Gastrointestinal Disease; Infectious Disease; Capsule Endoscopy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Complete Observation

  The number of participants with complete observation. Complete observation of the mucosa means over 90% of the mucosa observed in gastric cardia, fundus, body, angulus, antrum and pylorus.

  During the procedure

Secondary Outcomes (4)

• Maneuverability Score

  During the procedure

• Gastric Examination Time(GET)

  During the procedure

• the Comfort and Acceptability of Patients

  After the procedure(within 5 days)

• The Total Number of Patients Who Who Had a Diagnosis of Positive Findings

  after the procedure(within 5 days)

Other Outcomes (1)

• Adverse Events

  During and within 2 weeks after the procedure

Study Arms (2)

Non-contact MCE examination

EXPERIMENTAL

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. In order to simplify the examination procedure, the data recorder was put on the examination bed. The patient lay down after swallowing the capsule under the remote guidance of the endoscopist.

Device: non-contact magnetically-controlled capsule endoscopy

MCE examination

ACTIVE COMPARATOR

After an overnight fasting and drinking 1000 mL water and simethicone for gastric dilatation and preparation, the subjects put on the data recorder with the help of an endoscopist. Then, the endoscopist activated the capsule with the capsule locator. The patient was instructed to assume the supine or 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 face to face, the subject turned over on the bed to complete the examination.

Device: non-contact magnetically-controlled capsule endoscopy

Interventions

non-contact magnetically-controlled capsule endoscopy DEVICE

The novel non-contact magnetically-controlled capsule endoscopy (MCE) system (Ankon Technologies, Wuhan, China) (Figure 1) added a remote control workstation and an audio-visual exchange system to the original well-establish MCE system, which consisted of a robotic magnetic arm, a workstation (currently bypassed) and a capsule endoscope.

MCE examination; Non-contact MCE examination

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed the informed consents before joining this study

You may not qualify if:

• (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.

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

Related Publications (5)

• Chen YZ, Pan J, Luo YY, Jiang X, Zou WB, Qian YY, Zhou W, Liu X, Li ZS, Liao Z. Detachable string magnetically controlled capsule endoscopy for complete viewing of the esophagus and stomach. Endoscopy. 2019 Apr;51(4):360-364. doi: 10.1055/a-0856-6845. Epub 2019 Mar 1.

  PMID: 30822803 BACKGROUND

• Jiang X, Pan J, Li ZS, Liao Z. Standardized examination procedure of magnetically controlled capsule endoscopy. VideoGIE. 2019 May 30;4(6):239-243. doi: 10.1016/j.vgie.2019.03.003. eCollection 2019 Jun. No abstract available.

  PMID: 31194028 BACKGROUND

• Chiu PWY, Ng SC, Inoue H, Reddy DN, Ling Hu E, Cho JY, Ho LK, Hewett DG, Chiu HM, Rerknimitr R, Wang HP, Ho SH, Seo DW, Goh KL, Tajiri H, Kitano S, Chan FKL. Practice of endoscopy during COVID-19 pandemic: position statements of the Asian Pacific Society for Digestive Endoscopy (APSDE-COVID statements). Gut. 2020 Jun;69(6):991-996. doi: 10.1136/gutjnl-2020-321185. Epub 2020 Apr 2.

  PMID: 32241897 BACKGROUND

• Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Pilot Feasibility Stud. 2016 Oct 21;2:64. doi: 10.1186/s40814-016-0105-8. eCollection 2016.

  PMID: 27965879 BACKGROUND

• Jiang B, Qian YY, Pan J, Jiang X, Wang YC, Zhu JH, Zou WB, Zhou W, Li ZS, Liao Z. Second-generation magnetically controlled capsule gastroscopy with improved image resolution and frame rate: a randomized controlled clinical trial (with video). Gastrointest Endosc. 2020 Jun;91(6):1379-1387. doi: 10.1016/j.gie.2020.01.027. Epub 2020 Jan 22.

  PMID: 31981648 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Diseases; Communicable Diseases

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Digestive System Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Dr. Zhuan Liao
• Organization: National Clinical Research Center for Digestive Diseases Department of Gastroenterology

liaozhuan@smmu.edu.cn

21-31161004

Study Officials

• Zhuan Liao, MD

  Department of Gastroenterology, Changhai Hospital, the Naval Medical University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The investigators recruited 40 patients who have related symptom and healthy people mainly from outpatient clinic or hostipal health examination center. After fully understanding the procedure of nc-MCE，patients with informed consent were randomly divided into MCE group and nc-MCE group(1:1) by using a stratified block randomization(block size four)

Study Record Dates

• First Submitted: May 9, 2020
• First Posted: May 15, 2020
• Study Start: March 26, 2020
• Primary Completion: April 26, 2020
• Study Completion: May 20, 2020
• Last Updated: January 5, 2022
• Results First Posted: January 4, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)