A Multicenter, Prospective Study to Analyze the Efficacy and Safety of Microwave Ablation for the Treatment of Vascular Malformations
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 主要终点
- Lesion Volume Reduction
研究概览
简要总结
This clinical trial aims to assess the safety and efficacy of microwave ablation in treating vascular malformations, including both venous malformations (VM) and arteriovenous malformations (AVM). Vascular malformations are abnormal clusters of blood vessels that can cause pain, swelling, and functional impairment, significantly affecting a patient's quality of life. Microwave ablation is a minimally invasive treatment that uses heat to shrink abnormal vessels, but its effectiveness and safety for these conditions need further investigation.
The trial will enroll 150 patients (100 with venous malformations and 50 with arteriovenous malformations), all of whom will undergo a single session of microwave ablation. Ultrasound guidance will be used during the procedure to precisely target the lesions, while MRI will be used for both preoperative and postoperative evaluations to assess lesion size and track changes over time.
The primary goals of the study are to determine whether microwave ablation can reduce lesion size and improve symptoms such as pain and swelling. Additionally, the study will monitor adverse events to evaluate the safety of the procedure, including any potential complications like infection, bleeding, or nerve injury.
Patients will be followed for 12 months, with MRI scans taken at 1 month, 3 months, 6 months, and 12 months after the procedure to evaluate lesion shrinkage and monitor for any recurrence. Clinical symptoms will also be assessed at these time points to track improvement.
This study could provide important data on the safety and efficacy of microwave ablation, potentially offering a less invasive treatment option for patients with vascular malformations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with clinically diagnosed vascular malformations (venous malformations (VM) or arteriovenous malformations (AVM)) confirmed by MRI or ultrasound.
- •Presence of symptomatic lesions (pain, swelling, functional impairment, or ulceration) that require treatment.
- •Lesions that are amenable to microwave ablation based on preoperative clinical and imaging assessment.
- •Ability to provide informed consent or parental consent for minors (if applicable).
排除标准
- •Capillary malformations or congenital arteriovenous fistula.
- •Lesions that are too close to critical structures (e.g., major blood vessels or nerves) and cannot be safely treated.
- •Pregnancy or breastfeeding.
- •Severe coagulopathy or significant bleeding disorders.
- •Active infection at the treatment site.
- •Patients with severe uncontrolled systemic disease that could interfere with treatment or recovery.
- •Recent treatments (e.g., surgery, sclerotherapy, embolization) for the same lesion within the last 6 months.
研究组 & 干预措施
Microwave Ablation for Vascular Malformations
Patients in this arm will receive microwave ablation for the treatment of vascular malformations, including venous malformations (VM) and arteriovenous malformations (AVM). The procedure will be conducted under ultrasound guidance, and MRI will be used to assess lesion size and symptom improvement at preoperative and postoperative time points.
干预措施: Microwave Ablation (Device)
结局指标
主要结局
Lesion Volume Reduction
时间窗: Preoperative, 3 months, 6 months, 12 months
This outcome measures the reduction in the volume of vascular malformations, including both venous malformations (VM) and arteriovenous malformations (AVM), after microwave ablation. MRI will be used to assess lesion size before treatment and at 1 month, 3 months, 6 months, and 12 months post-procedure. The primary goal is to achieve a ≥50% reduction in lesion volume compared to the baseline preoperative size, indicating treatment success.
Swelling and Function Improvement (Venous Malformation Symptom Score - VMSS)
时间窗: Preoperative, 1 month, 3 months, 6 months, 12 months
This outcome evaluates the improvement in symptoms such as swelling and functional impairment caused by the vascular malformation. The Venous Malformation Symptom Score (VMSS) will be used, which includes a comprehensive assessment of symptoms like pain, swelling, and the ability to perform daily activities. The VMSS will be measured preoperatively and at follow-up visits at 1 month, 3 months, 6 months, and 12 months post-treatment. A ≥50% reduction in symptom score will be considered a significant improvement.
次要结局
- Pain Reduction (Visual Analog Scale - VAS)(Preoperative, 1 month, 3 months, 6 months, 12 months)
- Adverse Events (Incidence and Severity)(1 month, 3 months, 6 months, 12 months)
研究者
Chunshui He
Ph.D , Chief Physician of Vascular Surgery , Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu University of Traditional Chinese Medicine