Infectious Disease Clinical Trial
Official title:
Feasibility of Non-contact Magnetically-controlled Capsule Endoscopy During COVID-19 Pandemic: a Prospective, Open-label, Pilot, Randomized Trial
Verified date | December 2021 |
Source | Changhai Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | May 20, 2020 |
Est. primary completion date | April 26, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Changhai Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Changhai Hospital |
China,
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. — View 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. — View 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. eCollection 2016. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Adverse Events | Each patient was followed up for 2 weeks by telephone and hospital information system to confirm capsule excretion and any adverse events (AEs), including COVID-19 infection. | During and within 2 weeks after the procedure | |
Primary | Number of Participants With Complete Observation | The number of participants with complete observation. Complete observation of the mucosa means over 90% of the mucosa observed in gastric cardia, fundus, body, angulus, antrum and pylorus. | During the procedure | |
Secondary | 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 and the range of total score from 0 to 20. The higher the score, the better the maneuverability. | During the procedure | |
Secondary | Gastric Examination Time(GET) | GET was defined as the 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 by two sub questionnaires, which was pre-procedure patient perception (3 items, ranged from 0 to 12 ) and post-procedure patient satisfaction (12 items, ranged from 0 to 48) .The higher the score, the worse the patient's satisfaction. | After the procedure(within 5 days) | |
Secondary | The Total Number of Patients Who Who Had a Diagnosis of Positive Findings | It was calculated using the following formula: number of patients with positive findings divided by the total number of patients that underwent examination. | after the procedure(within 5 days) |
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