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Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05058482
Study type Interventional
Source Suzhou Hengruihongyuan Medical Technology Co. LTD
Contact Jianmin Liu, Doctor
Phone 13901780638
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date October 17, 2021
Completion date October 17, 2024

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