Clinical trial NCT04389333: Feasibility of Non-contact Magnetically-controlled Capsule Endoscopy During COVID-19 Pandemic
Official title: Feasibility of Non-contact Magnetically-controlled Capsule Endoscopy During COVID-19 Pandemic: a Prospective, Open-label, Pilot, Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Disease
Infectious Disease
Capsule Endoscopy
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2020-05-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators recruited 40 patients who have related symptom and healthy people mainly from outpatient clinic or hostipal health examination center. After fully understanding the procedure of nc-MCE，patients with informed consent were randomly divided into MCE group and nc-MCE group(1:1) by using a stratified block randomization(block size four)
Primary purpose: PREVENTION

Brief summary: In December 2019, an outbreak of pneumonia associated with a novel coronavirus named as severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) was reported in Wuhan city, China, and spread exponentially throughout China and other countries in the following weeks.

It is recommended that elective endoscopies should be deferred during the COVID-19 outbreak for the potential transmission between patients and medical staff in the statements of Asian Pacific Society for Digestive Endoscopy (APSDE-COVID statements). Therefore, exploring an alternative for patients with the requirements of endoscopy during the outbreak is of great importance.

Herein,the investigators developed an novel non-contact magnetically-controlled capsule endoscopy (Nc-MCE) system (Figure 1) adds a remote control workstation and a audio-visual exchange system to the original well-established MCE system.

This study was a open-label, prospective, randomized controlled study approved by the institutional review board of Shanghai Changhai Hospital. It was designed to evaluate the diagnostic utility, safety, feasibility and patients acceptability of Nc-MCE in patients with an indication of endoscopy, and comparing it with the result of MCE.

Detailed description: The nc-MCE system added a remote control workstation and an audio-visual exchange system to the original well-establish MCE system.Conventional protective measures could be adopted to endoscopist. Although the endoscopist and the patient are in different rooms, the endoscopist was able to see the patient and communicate with him or her through the audio-visual exchange system all the time. In order to simplify the examination procedure, the data recorder was putted on the examination bed. The patient lay down after swallowing the capsule under the remote guidance of the endoscopist.And the endoscopist of MCE and nc-MCE was the same one with experience of more than 1000 cases of MCCG operation.

The investigators recruited 40 patients who have related symptom and healthy people mainly from outpatient clinic or hospital health examination center. After fully understanding the procedure of nc-MCE, patients with informed consent were randomly divided into MCE group and nc-MCE group(1:1) by using a stratified block randomization(block size four).

The basic characteristics of the enrolled patients were prospectively collected. The primary endpoint was the maneuverability score evaluated by endoscopist. And the investigators choose the gastric examination time,the comfort and acceptability of patients, diagnostic yield and completeness of gastric examination as the secondary endpoint. The safety endpoint of nc-MCE was evaluated by the occurrence of adverse events.

Eligibility criteria: Inclusion Criteria:

Signed the informed consents before joining this study

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.

Primary outcomes:
measure: Number of Participants With Complete Observation
timeFrame: During the procedure
Secondary outcomes:
measure: Maneuverability Score
timeFrame: During the procedure
measure: Gastric Examination Time(GET)
timeFrame: During the procedure
measure: the Comfort and Acceptability of Patients
timeFrame: After the procedure(within 5 days)
measure: The Total Number of Patients Who Who Had a Diagnosis of Positive Findings
timeFrame: after the procedure(within 5 days)
Other outcomes:
measure: Adverse Events
timeFrame: During and within 2 weeks after the procedure
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
affiliation: Department of Gastroenterology, Changhai Hospital, the Naval Medical University
name: Zhuan Liao, MD
role: STUDY_CHAIR
References:
citation: Chen YZ, Pan J, Luo YY, Jiang X, Zou WB, Qian YY, Zhou W, Liu X, Li ZS, Liao Z. Detachable string magnetically controlled capsule endoscopy for complete viewing of the esophagus and stomach. Endoscopy. 2019 Apr;51(4):360-364. doi: 10.1055/a-0856-6845. Epub 2019 Mar 1.
citation: Jiang X, Pan J, Li ZS, Liao Z. Standardized examination procedure of magnetically controlled capsule endoscopy. VideoGIE. 2019 May 30;4(6):239-243. doi: 10.1016/j.vgie.2019.03.003. eCollection 2019 Jun. No abstract available.
citation: Chiu PWY, Ng SC, Inoue H, Reddy DN, Ling Hu E, Cho JY, Ho LK, Hewett DG, Chiu HM, Rerknimitr R, Wang HP, Ho SH, Seo DW, Goh KL, Tajiri H, Kitano S, Chan FKL. Practice of endoscopy during COVID-19 pandemic: position statements of the Asian Pacific Society for Digestive Endoscopy (APSDE-COVID statements). Gut. 2020 Jun;69(6):991-996. doi: 10.1136/gutjnl-2020-321185. Epub 2020 Apr 2.
citation: Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Pilot Feasibility Stud. 2016 Oct 21;2:64. doi: 10.1186/s40814-016-0105-8. eCollection 2016.
citation: Jiang B, Qian YY, Pan J, Jiang X, Wang YC, Zhu JH, Zou WB, Zhou W, Li ZS, Liao Z. Second-generation magnetically controlled capsule gastroscopy with improved image resolution and frame rate: a randomized controlled clinical trial (with video). Gastrointest Endosc. 2020 Jun;91(6):1379-1387. doi: 10.1016/j.gie.2020.01.027. Epub 2020 Jan 22.