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Tests treatment safety and results for Intracranial Arteriovenous Malformations
Official title Efficacy and Safety of the Liquid Embolic System (Tonbridge) for Endovascular Treatment of Cerebrovascular Malformations
ClinicalTrials.gov ID: NCT06479343
What this study is testing
- What it's testing
- The purpose of this study is to verify the efficacy and safety of the Liquid Embolic System (Tonbridge Medical Tech. Co., Ltd.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Age 18 to 80 years, any gender;
- Subject is suitable for endovascular treatment of cerebrovascular malformations;
- Subject is able to understand the purpose of the study, shows sufficient compliance with the study protocol and provides a signed informed consent...
You likely can't join if
- Intracranial hemorrhage within 1 month prior to treatment;
- The targeted embolization area needs to receive other treatments (surgical resection, SRS, other embolic materials) at the same time;
- Combination of other cerebrovascular malformations, such as cavernous vascular malformation;
- Severe stenosis or occlusion of cerebral feeding artery requiring surgical intervention;
- Intracranial tumor requiring surgical intervention;
- mRS score≥3;
See the full eligibility criteria
- Age 18 to 80 years, any gender;
- Subject is suitable for endovascular treatment of cerebrovascular malformations;
- Subject is able to understand the purpose of the study, shows sufficient compliance with the study protocol and provides a signed informed consent form.
- Intracranial hemorrhage within 1 month prior to treatment;
- The targeted embolization area needs to receive other treatments (surgical resection, SRS, other embolic materials) at the same time;
- Combination of other cerebrovascular malformations, such as cavernous vascular malformation;
- Severe stenosis or occlusion of cerebral feeding artery requiring surgical intervention;
- Intracranial tumor requiring surgical intervention;
- mRS score≥3;
- Heart, lung, liver and renal failure or other severe diseases;
- Known bleeding tendency, such as coagulation dysfunction (INR\>1.5);
- Known allergy to DMSO and contrast media, or contraindication to anticoagulant therapy;
- Pregnant or breastfeeding women, or who plan to become pregnant during the study;
- Subject is participating in other drug or medical device clinical trials at the time of signing informed consent;
- Other conditions judged by the investigators as unsuitable for enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
- Zhengzhou, Henan, China
- Nanjing, Jiangsu, China
- Changchun, Jilin, China
- Shenyang, Liaoning, China
- Jinan, Shandong, China
- Beijing, China
- Chengdu, China
- Guangzhou, China
- Hefei, China
- Jining, China
- Wuhan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China; Zhengzhou, Henan, China; Nanjing, Jiangsu, China; Changchun, Jilin, China; Shenyang, Liaoning, China; Jinan, Shandong, China and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.