Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06479343

Efficacy and Safety of the Liquid Embolic System (Tonbridge) for Endovascular Treatment of Cerebrovascular Malformations

Led by Ton-Bridge Medical Tech. Co., Ltd · Updated on 2024-09-19

170

Participants Needed

14

Research Sites

118 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Efficacy and Safety of the Liquid Embolic System (Tonbridge) for Endovascular Treatment of Cerebrovascular Malformations

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 80 years, any gender
  • Suitable for endovascular treatment of cerebrovascular malformations
  • Able to understand the study purpose, comply with the protocol, and provide signed informed consent
Not Eligible

You will not qualify if you...

  • Intracranial hemorrhage within 1 month before treatment
  • Need for other treatments (surgery, radiosurgery, other embolic materials) in the embolization area during treatment
  • Presence of other cerebrovascular malformations like cavernous vascular malformation
  • Severe narrowing or blockage of brain arteries requiring surgery
  • Brain tumors needing surgical treatment
  • Modified Rankin Scale score of 3 or higher
  • Severe heart, lung, liver, or kidney failure or other serious illnesses
  • Known bleeding problems or coagulation disorders (INR >1.5)
  • Known allergy to DMSO or contrast media or contraindication to anticoagulant therapy
  • Pregnant, breastfeeding, or planning pregnancy during the study
  • Participation in other drug or device clinical trials at consent
  • Other conditions deemed unsuitable by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 14 locations

1

Nanfang Hospital Southern Medical University

Guangzhou, Guangdong, China

Not Yet Recruiting

2

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Not Yet Recruiting

3

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Not Yet Recruiting

4

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Active, Not Recruiting

5

General Hospital of Eastern Theater Command

Nanjing, Jiangsu, China

Not Yet Recruiting

6

The First Hospital of Jilin University

Changchun, Jilin, China

Not Yet Recruiting

7

General Hospital of Northern Theater Command

Shenyang, Liaoning, China

Not Yet Recruiting

8

Qilu Hospital of Shandong University

Jinan, Shandong, China

Not Yet Recruiting

9

Xuanwu hospital Capital Medical University

Beijing, China

Actively Recruiting

10

Sichuan Academy of Medical Sciences Sichuan Provincial People's Hospital

Chengdu, China

Actively Recruiting

11

Guangdong Provincial People's Hospital

Guangzhou, China

Not Yet Recruiting

12

Anhui Provincial Hospital

Hefei, China

Not Yet Recruiting

13

Jining No.1 People's Hospital

Jining, China

Not Yet Recruiting

14

Tongji Hospital Tongji Medical College of HUST

Wuhan, China

Not Yet Recruiting

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Research Team

J

Jing Pan

CONTACT

J

Jin Zheng

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Efficacy and Safety of the Liquid Embolic System (Tonbridge) for Endovascular Treatment of Cerebrovascular Malformations | DecenTrialz