Feasibility of Remote MCE for Upper GI Tract Examination Under Five-generation Network
NCT ID: NCT04670692
Last Updated: 2021-09-24
Study Results
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Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2020-12-30
2021-07-30
Brief Summary
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Detailed Description
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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 5G-MCE system was provided by Ankon Technologies Co, Ltd (Shanghai, China), this system consists of three parts: remote console, remote control software (NaviRemoteCtrl), and remote connection software (NaviRemoteConn). The remote console (based in Shanghai), 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. 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.
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
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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5G-MCE examination
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.
5G-MCE examination
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.
MCE examination
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.
MCE examination
The endoscopist (W.Z.) performs the MCE examination procedure conventionally. And communicate with the volunteer face to face in the same examination room.
Interventions
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5G-MCE examination
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.
MCE examination
The endoscopist (W.Z.) performs the MCE examination procedure conventionally. And communicate with the volunteer face to face in the same examination room.
Eligibility Criteria
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Inclusion Criteria
2. Patients aged 18 years or older.
3. Both inpatients and outpatients.
4. Volunteers with or without abdominal complaints.
5. Able to provide informed consent.
Exclusion Criteria
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.
18 Years
ALL
Yes
Sponsors
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Changhai Hospital
OTHER
Responsible Party
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Zhuan Liao
Professor
Principal Investigators
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Zhuan Liao
Role: PRINCIPAL_INVESTIGATOR
Changhai Hospital
Locations
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Changhai Hospital
Shanghai, Shanghai Municipality, China
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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5G-MCE
Identifier Type: -
Identifier Source: org_study_id
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