Comprehensive Evaluation of the Clinical Application of
the Radial Endobronchial Ultrasound System
TONG Run1, DENG Mingming1, YANG Zhen2, SUN Jiayuan3, YIN Yan4, HOU Gang1,4
1. Department of Respiratory and Critical Care Medicine, Respiratory Center, China-Japan Friendship Hospital (National Center
for Respiratory Medicine/Institute of Respiratory Medicine, Chinese Academy of Medical Sciences/National Research Center for
Respiratory Diseases/World Health Organization Collaborating Center for Tobacco Cessation and Respiratory Disease Prevention),
Beijing 100029, China; 2. Department of Respiratory and Critical Care Medicine, PLA General Hospital, Beijing 100853, China;
3. Department of Respiratory and Critical Care Medicine, Respiratory Endoscopy Center, Shanghai Chest Hospital, Shanghai
Jiaotong University, Shanghai 200030, China; 4. Department of Respiratory and Critical Care Medicine, The First Hospital of China
Medical University, Shenyang Liaoning 110001, China
Abstract：Objective To compare the technical performance of Vsonic 600 B ultrasound imaging system (consisting of Vsonic 600
ultrasound image processor and Vsonic Pro2017C ultrasound probe) independently developed by Beijing Huake Chuangzhi Co., Ltd.
and the mainstream products of similar foreign high-frequency endobronchial ultrasound equipment (Olympus EU-ME2 ultrasound
endoscope image processor and the UM-S20-17S endoscope ultrasound probe) , and to summarize the advantages and disadvantages
of domestic products and provide a basis evidence for product improvement. Methods Through a multi-center self-controlled study,
the Vsonic 600 B ultrasound imaging system (experimental group) and the EU-ME2 related system (control group) were compared
in image excellence rate, image eligible rate, lesion recognition rate, machine operation time, machine safety, machine stability and
the occurrence of adverse events. Results A total of 75 subjects were enrolled, the ratio of male to female was 42∶33, with the age
ranging (57.30±10.46) years. The imaging capability of the ultrasound probes of the experimental group was equivalent to that of
the control probes; thus the ultrasound imaging effect of the experimental equipment was not inferior to the control equipment. In this
study, the median operation time of the experimental group and the control group was both 8 min, there was no statistical difference
(P>0.05). The statistical analysis of the machine safety and the stability showed that neither the experimental group nor the control
group had any malfunction during the clinical trial, and the machine was stable and safe. There were no adverse events in either
group. Conclusion This clinical trial verifies the safety and effectiveness of the domestic Vsonic 600 B ultrasound imaging system
in endobronchial ultrasound imaging of trachea and bronchus are equivalent to those of imported similar products on the market.
基金资助:国家重点研发项目（ 2 0 1 8 Y F C 0 1 1 6 2 0 3 ；
童润1，邓明明1，杨震2，孙加源3，尹燕4，侯刚1,4. 支气管内径向超声成像系统临床应用的综合评价研究[J]. 中国医疗设备, 2022, 37(7): 68-71.
TONG Run1, DENG Mingming1, YANG Zhen2, SUN Jiayuan3, YIN Yan4, HOU Gang1,4. Comprehensive Evaluation of the Clinical Application of
the Radial Endobronchial Ultrasound System. China Medical Devices, 2022, 37(7): 68-71.