Ignite Creation Date:
2024-07-17 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06479343
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-24
Brief Title:
Efficacy and Safety of the Liquid Embolic System Tonbridge for Endovascular Treatment of Cerebrovascular Malformations
Sponsor:
Zhuhai Tonbridge Medical Tech Co Ltd
Organization:
Zhuhai Tonbridge Medical Tech Co Ltd
Study Overview
Official Title:
Efficacy and Safety of the Liquid Embolic System Tonbridge for Endovascular Treatment of Cerebrovascular Malformations a Prospective Multi-center Randomized Parallel Positive Controlled Non-inferiority Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to verify the efficacy and safety of the Liquid Embolic System Tonbridge Medical Tech Co Ltd Suzhou for the treatment of cerebrovascular malformations
Detailed Description:
This is a prospective multi-center randomized parallel positive controlled non-inferiority trial This clinical trial is conducted at more than 2 centers in China and patients who intend to be treated with liquid embolic system for cerebrovascular malformations are enrolled Eligible patients are randomized into experimental group using Liquid Embolic System Tonbridge or control group using Onyx Liquid Embolic System Medtronic in a 11 ratio The purpose of this study is to evaluate the effectiveness and safety of the Liquid Embolic System Tonbridge
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None