Spots Global Cancer Trial Database for Non-adhesive Liquid Embolic System in the Embolization of Cerebral Arteriovenous Malformations
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Trial Identification
Brief Title: Non-adhesive Liquid Embolic System in the Embolization of Cerebral Arteriovenous Malformations
Official Title: A Prospective, Multi-center, Randomized Parallel Controlled Study on the Safety and Effectiveness of the Non-adhesive Liquid Embolic System in the Embolization of Cerebral Arteriovenous Malformations
Study ID: NCT05058482
Conditions
Interventions
Study Description
Brief Summary: This clinical trial is to verify the safety and effectiveness of the Non-adhesive Liquid Embolic System(NALES) produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd. in the process of clinical use to support the application of the National Medical Products Administration ( NMPA) product registration approval.
Detailed Description: A prospective, multicenter, randomized controlled trial was used in this study. Onyx Liquid Embolic System and Marathon Flow Directed Micro Catheter, which were registered and marketed in China and had good effect in the industry, were selected as the control devices. Subjects requiring cerebral arteriovenous malformation embolization were selected to participate in the trial based on pathological conditions and inclusion/exclusion criteria, and the use of test products or control products was determined based on central randomized results. Imaging data involving the main evaluation criteria were evaluated uniformly by the blind evaluators of the leading unit, so as to reduce the bias caused by subjective factors of different evaluators.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Zhujiang Hospital of Southern Medical University, Guangzhou, Guangdong, China
Nan Fang Hospital, Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China
The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China
Henan Provincial People's Hospital, Zhengzhou, Henan, China
Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China
The First People's Hospital of Changzhou, Changzhou, Jiangsu, China
Nanjng Drum Tower Hospital, Nanjing, Jiangsu, China
General Hospital of Eastern Theater Command, Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
Huashan Hospital ,Fudan University, Shanghai, Shanghai, China
Shanghai Changhai Hospital, Shanghai, Shanghai, China
The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Contact Details
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