Non-contact Endoscopy at Covid-19 Outbreak

• ClinicalTrials.gov Identifier: NCT04320953
• Recruitment Status: Completed
• First Posted: March 25, 2020
• Last Update Posted: April 17, 2020
• Sponsor: Changhai Hospital
• Information provided by (Responsible Party): Zhuan Liao, Changhai Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Gastrointestinal Disease; Infectious Disease	Device: Non-contact MCE system	Not Applicable

Detailed Description:

The novel non-contact magnetically-controlled capsule endoscopy (MCE) system (Ankon Technologies, China) adds a remote control workstation and a audio-visual exchange system to the original well-establish MCE system, which consists of a robotic magnetic arm, a workstation (now bypassed) and a capsule endoscope, and boasts a 90% sensitivity and 94% specificity for diagnosing gastric focal lesions. This feasibility study aims to evaluate the technical success, clinical success and adverse events of the first clinical application of non-contact MCE system.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Non-contact Endoscopy at Covid-19 Outbreak
• Actual Study Start Date: March 16, 2020
• Actual Primary Completion Date: March 26, 2020
• Actual Study Completion Date: April 9, 2020

Arms and Interventions

Arm

Intervention/treatment

Experimental: Non-contact MCE examination; Study subject in this arm receives non-contact MCE examination.

Device: Non-contact MCE system; 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.

Outcome Measures

Primary Outcome Measures :

1. Technical success [ Time Frame: During the procedure ]
   Maneuvarability of the remote control MCE system

Secondary Outcome Measures :

1. Clinical success [ Time Frame: During the procedure ]
   Complete observation of the mucosa (>90% of the mucosa observed) in gastric cardia, fundus, body, angulus, antrum and pylorus
2. Adverse events [ Time Frame: During and within 2 weeks after the procedure ]
   Adverse events during and after the procedure

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Signed the informed consents before joining this study

Exclusion Criteria:

• 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

Contacts and Locations

Locations

China

Changhai Hospital

Shanghai, China, 200433

Sponsors and Collaborators

Changhai Hospital

Investigators

• Principal Investigator: Zhuan Liao, MD; Changhai Hospital

More Information

Publications:

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.

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.

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.

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.

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.

• Responsible Party: Zhuan Liao, Principal Investigator, Changhai Hospital
• ClinicalTrials.gov Identifier: NCT04320953
• Other Study ID Numbers: ncMCE1
• First Posted: March 25, 2020
• Last Update Posted: April 17, 2020
• Last Verified: April 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Communicable Diseases; Infections; Gastrointestinal Diseases; Digestive System Diseases; Disease Attributes; Pathologic Processes