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Non-contact Endoscopy at Covid-19 Outbreak

Primary Purpose

Gastrointestinal Disease, Infectious Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Non-contact MCE system
Sponsored by
Changhai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Gastrointestinal Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Changhai Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Non-contact MCE examination

Arm Description

Study subject in this arm receives non-contact MCE examination.

Outcomes

Primary Outcome Measures

Technical success
Maneuvarability of the remote control MCE system

Secondary Outcome Measures

Clinical success
Complete observation of the mucosa (>90% of the mucosa observed) in gastric cardia, fundus, body, angulus, antrum and pylorus
Adverse events
Adverse events during and after the procedure

Full Information

First Posted
March 21, 2020
Last Updated
April 15, 2020
Sponsor
Changhai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04320953
Brief Title
Non-contact Endoscopy at Covid-19 Outbreak
Official Title
Non-contact Endoscopy at Covid-19 Outbreak
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 16, 2020 (Actual)
Primary Completion Date
March 26, 2020 (Actual)
Study Completion Date
April 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Disease, Infectious Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-contact MCE examination
Arm Type
Experimental
Arm Description
Study subject in this arm receives non-contact MCE examination.
Intervention Type
Device
Intervention Name(s)
Non-contact MCE system
Intervention Description
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.
Primary Outcome Measure Information:
Title
Technical success
Description
Maneuvarability of the remote control MCE system
Time Frame
During the procedure
Secondary Outcome Measure Information:
Title
Clinical success
Description
Complete observation of the mucosa (>90% of the mucosa observed) in gastric cardia, fundus, body, angulus, antrum and pylorus
Time Frame
During the procedure
Title
Adverse events
Description
Adverse events during and after the procedure
Time Frame
During and within 2 weeks after the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhuan Liao, MD
Organizational Affiliation
Changhai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changhai Hospital
City
Shanghai
ZIP/Postal Code
200433
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
32160451
Citation
Hollander JE, Carr BG. Virtually Perfect? Telemedicine for Covid-19. N Engl J Med. 2020 Apr 30;382(18):1679-1681. doi: 10.1056/NEJMp2003539. Epub 2020 Mar 11. No abstract available.
Results Reference
background
PubMed Identifier
27211503
Citation
Liao Z, Hou X, Lin-Hu EQ, Sheng JQ, Ge ZZ, Jiang B, Hou XH, Liu JY, Li Z, Huang QY, Zhao XJ, Li N, Gao YJ, Zhang Y, Zhou JQ, Wang XY, Liu J, Xie XP, Yang CM, Liu HL, Sun XT, Zou WB, Li ZS. Accuracy of Magnetically Controlled Capsule Endoscopy, Compared With Conventional Gastroscopy, in Detection of Gastric Diseases. Clin Gastroenterol Hepatol. 2016 Sep;14(9):1266-1273.e1. doi: 10.1016/j.cgh.2016.05.013. Epub 2016 May 20.
Results Reference
background
PubMed Identifier
29753039
Citation
Zhao AJ, Qian YY, Sun H, Hou X, Pan J, Liu X, Zhou W, Chen YZ, Jiang X, Li ZS, Liao Z. Screening for gastric cancer with magnetically controlled capsule gastroscopy in asymptomatic individuals. Gastrointest Endosc. 2018 Sep;88(3):466-474.e1. doi: 10.1016/j.gie.2018.05.003. Epub 2018 May 9.
Results Reference
background
PubMed Identifier
31511198
Citation
Tai FWD, Ching HL, Hale MF, McAlindon ME. Upper gastrointestinal endoscopy: can we cut the cord? Lancet Gastroenterol Hepatol. 2019 Oct;4(10):749-751. doi: 10.1016/S2468-1253(19)30262-6. No abstract available.
Results Reference
background
PubMed Identifier
30005825
Citation
Jiang X, Qian YY, Liu X, Pan J, Zou WB, Zhou W, Luo YY, Chen YZ, Li ZS, Liao Z. Impact of magnetic steering on gastric transit time of a capsule endoscopy (with video). Gastrointest Endosc. 2018 Oct;88(4):746-754. doi: 10.1016/j.gie.2018.06.031. Epub 2018 Jul 11.
Results Reference
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Non-contact Endoscopy at Covid-19 Outbreak

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