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Gastrointestinal DiseaseNCT04670692

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

A study testing 5G-MCE examination and MCE examination in people with Gastrointestinal Disease, run by Changhai Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Gastrointestinal Disease
What is being tested?
5G-MCE examination and MCE examination
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
30 Dec 2020to 30 Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Changhai Hospital

    Shanghai, Shanghai Municipality, 200433

Other trials in China

About this study

Official title: Feasibility of Remote Magnetically Controlled Capsule Endoscopy for Upper Gastrointestinal Tract Examination Under Five-generation Network: a Prospective, Open-label, Pilot Trial

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.

Read the detailed description

With the combination of robotic and 5G network communication technology, telemedicine becomes more and more feasible and efficient. On the one hand, telemedicine can conserve and optimize medical resources, providing high-quality medical services to unbalanced areas, such as rural areas, stricken areas and battlefields. On the other hand, telemedicine can reduce the time spent by patients waiting for examination and treatment and thus prevent diseases from worsening.

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.

Being tested
5G-MCE examination, MCE examination
Keywords
capsule endoscopy, magnetically, 5G network, telemedicine
Medical subject headings
Gastrointestinal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 5G-MCE examinationOther

    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 examinationOther

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

Study groups in NCT04670692
Study groupRoleWhat they receive
5G-MCE examinationExperimentalThere 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.
Receives: Other: 5G-MCE examination
MCE examinationActive comparatorThere 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.
Receives: Other: MCE examination

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: During the procedure

Secondary outcomes (5)
  1. Gastric examination time(GET)

    GET was defined as the time time taken for the endoscopist to complete the gastric examination to his or her satisfaction.

    Measured: During the procedure

  2. the comfort and acceptability of patients

    The investigators use a satisfaction questionnaire to evaluate the comfort and acceptability of each patient

    Measured: After the procedure(within 5 days)

  3. diagnostic yield

    Diagnosis based on the data of 5G-MCE by two endoscopist

    Measured: after the procedure(within 5 days)

  4. Adverse events

    Adverse events during and after the procedure

    Measured: During and within 2 weeks after the procedure

  5. Clinical success

    Complete observation of the mucosa (>90% of the mucosa observed) in gastric cardia, fundus, body, angulus, antrum and pylorus.

    Measured: During the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2020
  2. Study start30 Dec 2020
  3. Primary completion30 May 2021
  4. Study completion30 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04670692
Sponsor's protocol ID
5G-MCE
Status last verified
Sep 2021
First submitted
11 Dec 2020
Last updated
24 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23687601
  • 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.

    PubMed 25590177
  • 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.

    PubMed 27211503
  • 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.

    PubMed 29779696
  • 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.

    PubMed 29753039
  • 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.

    PubMed 30581462
  • 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.

    PubMed 29110963
  • 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.

    PubMed 30560329
  • 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.

    PubMed 30005825
  • 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.

    PubMed 32898686
  • 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.

    PubMed 32349962
  • 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.

    PubMed 32700149
  • 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.

    PubMed 36416805

Questions about this trial

What is this clinical trial studying?

A study testing 5G-MCE examination and MCE examination in people with Gastrointestinal Disease, run by Changhai Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maneuverability score (time frame: During the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04670692, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2021; AzTrials last refreshed its copy on 6 Nov 2026.

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