NCT04320953

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 16, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 25, 2020

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2020

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2020

Completed
Last Updated

April 17, 2020

Status Verified

April 1, 2020

Enrollment Period

10 days

First QC Date

March 21, 2020

Last Update Submit

April 15, 2020

Conditions

Gastrointestinal DiseaseInfectious Disease

Outcome Measures

Primary Outcomes (1)

  • Technical success

    Maneuvarability of the remote control MCE system

    During the procedure

Secondary Outcomes (2)

  • Clinical success

    During the procedure

  • Adverse events

    During and within 2 weeks after the procedure

Study Arms (1)

Non-contact MCE examination

EXPERIMENTAL

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

Device: Non-contact MCE system

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.

Non-contact MCE examination

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed the informed consents before joining this study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital

Shanghai, 200433, China

Location

Related Publications (5)

  • 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.

    PMID: 32160451BACKGROUND

  • 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.

    PMID: 27211503BACKGROUND

  • 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.

    PMID: 29753039BACKGROUND

  • 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.

    PMID: 31511198BACKGROUND

  • 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.

    PMID: 30005825BACKGROUND

MeSH Terms

Conditions

Gastrointestinal DiseasesCommunicable Diseases

Condition Hierarchy (Ancestors)

Digestive System DiseasesInfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Zhuan Liao, MD

    Changhai Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 21, 2020

First Posted

March 25, 2020

Study Start

March 16, 2020

Primary Completion

March 26, 2020

Study Completion

April 9, 2020

Last Updated

April 17, 2020

Record last verified: 2020-04

Locations

CN(1)