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

Gastrointestinal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04670692
• Other study ID #: 5G-MCE
• Status: Completed
• Phase: N/A
• Start date: December 30, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: September 2021
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Gender is not limited.

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:

1. dysphagia or symptoms of gastric outlet obstruction, suspected or known intestinal stenosis,overt gastrointestinal bleeding,fistulas and strictures;

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.

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Disease
• Gastrointestinal Diseases

Intervention

Other:
• 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.

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

References & Publications (12)

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. — View Citation

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. — View 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. — View Citation

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. Review. — View Citation

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. — View 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. — View Citation

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. — View Citation

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. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	During the procedure
Secondary	the comfort and acceptability of patients	The investigators use a satisfaction questionnaire to evaluate the comfort and acceptability of each patient	After the procedure(within 5 days)
Secondary	diagnostic yield	Diagnosis based on the data of 5G-MCE by two endoscopist	after the procedure(within 5 days)
Secondary	Adverse events	Adverse events during and after the procedure	During and within 2 weeks after the procedure
Secondary	Clinical success	Complete observation of the mucosa (>90% of the mucosa observed) in gastric cardia, fundus, body, angulus, antrum and pylorus.	During the procedure