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

NCT04670692 | Completed

• 1 other identifier: 5G-MCE
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastrointestinal Disease

Keywords

capsule endoscopy, magnetically; 5G network; telemedicine

Outcome Measures

Primary Outcomes (1)

• Maneuverability score

  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 Outcomes (5)

• Gastric examination time(GET)

  During the procedure

• the comfort and acceptability of patients

  After the procedure(within 5 days)

• diagnostic yield

  after the procedure(within 5 days)

• Adverse events

  During and within 2 weeks after the procedure

• Clinical success

  During the procedure

Study Arms (2)

5G-MCE examination

EXPERIMENTAL

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

MCE examination

ACTIVE COMPARATOR

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

Interventions

5G-MCE examination OTHER

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.

5G-MCE examination

MCE examination OTHER

The endoscopist (W.Z.) performs the MCE examination procedure conventionally. And communicate with the volunteer face to face in the same examination room.

MCE examination

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• dysphagia or symptoms of gastric outlet obstruction, suspected or known intestinal stenosis,overt gastrointestinal bleeding,fistulas and strictures;
• history of upper gastrointestinal surgery or suspected delayed gastric emptying;
• Patients with poor general condition,asthma or claus trophobia;
• Implanted metallic devices such as pacemakers,defibrillators, artificial heart valves or joint prostheses;
• Pregnancy or mentally ill person;
• currently participating in another clinical study;
• communication obstacles persons.

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Related Publications (13)

• Liao Z, Duan XD, Xin L, Bo LM, Wang XH, Xiao GH, Hu LH, Zhuang SL, Li ZS. Feasibility and safety of magnetic-controlled capsule endoscopy system in examination of human stomach: a pilot study in healthy volunteers. J Interv Gastroenterol. 2012 Oct-Dec;2(4):155-160. doi: 10.4161/jig.23751. Epub 2012 Oct 1.

  PMID: 23687601 BACKGROUND

• Zou WB, Hou XH, Xin L, Liu J, Bo LM, Yu GY, Liao Z, Li ZS. Magnetic-controlled capsule endoscopy vs. gastroscopy for gastric diseases: a two-center self-controlled comparative trial. Endoscopy. 2015 Jun;47(6):525-8. doi: 10.1055/s-0034-1391123. Epub 2015 Jan 15.

  PMID: 25590177 BACKGROUND

• 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: 27211503 BACKGROUND

• Qian YY, Zhu SG, Hou X, Zhou W, An W, Su XJ, McAlindon ME, Li ZS, Liao Z. Preliminary study of magnetically controlled capsule gastroscopy for diagnosing superficial gastric neoplasia. Dig Liver Dis. 2018 Oct;50(10):1041-1046. doi: 10.1016/j.dld.2018.04.013. Epub 2018 Apr 24.

  PMID: 29779696 BACKGROUND

• 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: 29753039 BACKGROUND

• Chen X, Gao F, Zhang J. Screening for Gastric and Small Intestinal Mucosal Injury with Magnetically Controlled Capsule Endoscopy in Asymptomatic Patients Taking Enteric-Coated Aspirin. Gastroenterol Res Pract. 2018 Nov 15;2018:2524698. doi: 10.1155/2018/2524698. eCollection 2018.

  PMID: 30581462 BACKGROUND

• Zhu SG, Qian YY, Tang XY, Zhu QQ, Zhou W, Du H, An W, Su XJ, Zhao AJ, Ching HL, McAlindon ME, Li ZS, Liao Z. Gastric preparation for magnetically controlled capsule endoscopy: A prospective, randomized single-blinded controlled trial. Dig Liver Dis. 2018 Jan;50(1):42-47. doi: 10.1016/j.dld.2017.09.129. Epub 2017 Oct 6.

  PMID: 29110963 BACKGROUND

• Wang YC, Pan J, Jiang X, Su XJ, Zhou W, Zou WB, Qian YY, Chen YZ, Liu X, Yu J, Yan XN, Zhao AJ, Li ZS, Liao Z. Repetitive Position Change Improves Gastric Cleanliness for Magnetically Controlled Capsule Gastroscopy. Dig Dis Sci. 2019 May;64(5):1297-1304. doi: 10.1007/s10620-018-5415-7. Epub 2018 Dec 17.

  PMID: 30560329 BACKGROUND

• 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: 30005825 BACKGROUND

• Li JO, Liu H, Ting DSJ, Jeon S, Chan RVP, Kim JE, Sim DA, Thomas PBM, Lin H, Chen Y, Sakomoto T, Loewenstein A, Lam DSC, Pasquale LR, Wong TY, Lam LA, Ting DSW. Digital technology, tele-medicine and artificial intelligence in ophthalmology: A global perspective. Prog Retin Eye Res. 2021 May;82:100900. doi: 10.1016/j.preteyeres.2020.100900. Epub 2020 Sep 6.

  PMID: 32898686 BACKGROUND

• Hong Z, Li N, Li D, Li J, Li B, Xiong W, Lu L, Li W, Zhou D. Telemedicine During the COVID-19 Pandemic: Experiences From Western China. J Med Internet Res. 2020 May 8;22(5):e19577. doi: 10.2196/19577.

  PMID: 32349962 BACKGROUND

• Zheng J, Wang Y, Zhang J, Guo W, Yang X, Luo L, Jiao W, Hu X, Yu Z, Wang C, Zhu L, Yang Z, Zhang M, Xie F, Jia Y, Li B, Li Z, Dong Q, Niu H. 5G ultra-remote robot-assisted laparoscopic surgery in China. Surg Endosc. 2020 Nov;34(11):5172-5180. doi: 10.1007/s00464-020-07823-x. Epub 2020 Jul 22.

  PMID: 32700149 BACKGROUND

• Zhang T, Chen YZ, Jiang X, He C, Pan J, Zhou W, Hu JP, Liao Z, Li ZS. 5G-based remote magnetically controlled capsule endoscopy for examination of the stomach and small bowel. United European Gastroenterol J. 2023 Feb;11(1):42-50. doi: 10.1002/ueg2.12339. Epub 2022 Nov 23.

  PMID: 36416805 DERIVED

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Zhuan Liao

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 17, 2020
• Study Start: December 30, 2020
• Primary Completion: May 30, 2021
• Study Completion: July 30, 2021
• Last Updated: September 24, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)