Microwave Ablation for Treatment of Vascular Malformations: Efficacy and Safety

Официальное название

A Multicenter, Prospective Study to Analyze the Efficacy and Safety of Microwave Ablation for the Treatment of Vascular Malformations

Обзор

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.

Вмешательства

• Устройство Microwave Ablation
  This intervention involves the use of a microwave ablation catheter to treat vascular malformations, including venous malformations (VM) and arteriovenous malformations (AVM). The procedure is minimally invasive and performed under local anesthesia, with the lesion targeted using ultrasound guidance. Post-procedure imaging with MRI will be used to assess lesion size reduction and symptom improvement at several time points (preoperative, 1 month, 3 months, 6 months, and 12 months).

Первичные конечные точки

• Lesion Volume Reduction [Срок оценки: Preoperative, 3 months, 6 months, 12 months]
• Swelling and Function Improvement (Venous Malformation Symptom Score - VMSS) [Срок оценки: Preoperative, 1 month, 3 months, 6 months, 12 months]

Вторичные конечные точки (2)

• Pain Reduction (Visual Analog Scale - VAS) [Срок оценки: Preoperative, 1 month, 3 months, 6 months, 12 months]
• Adverse Events (Incidence and Severity) [Срок оценки: 1 month, 3 months, 6 months, 12 months]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Chen J, Dou J, Han Z, Liang P. Microwave Ablation for Refractory Giant Maxillofacial Arteriovenous Malformation: A Case Report. Laryngoscope. 2023 Nov;133(11):2984-2987. doi: 10.1002/lary.30664. Epub 2023 Mar 24. PMID 36960915
• Fang MR, Wang L, Li TT, Deng XW, Li XY, Lu M. [Comparison of efficacy between ultrasound-guided microwave ablation and sclerosing agents for the treatment of head and neck venous malformations]. Zhonghua Yi Xue Za Zhi. 2025 Apr 22;105(16):1256-1261. doi: 10.3760/cma.j.cn112137-20241116-02571. Chinese. PMID 40262997
• Yin HH, Wen R, Lin P, Yang H, Hu M, Yang H. Ultrasound-guided microwave ablation of soft tissue venous malformations. J Vasc Surg Venous Lymphat Disord. 2023 May;11(3):605-609. doi: 10.1016/j.jvsv.2022.11.003. Epub 2022 Dec 24. PMID 36574903
• Wang L, Lu M, Zhuang M, Liang Y, Wang SS, Li JM. Microwave ablation with hydrodissection used for the treatment of vascular malformations: effectiveness and safety study. Front Oncol. 2024 Jun 4;14:1146972. doi: 10.3389/fonc.2024.1146972. eCollection 2024. PMID 38894863
• Huang S, Xu F, Li X, Zhang H, Chen J, Zhao Z, Zhang J, Peng L, Kong X. Efficacy of ultrasound-guided microwave ablation for vascular malformations in children. J Vasc Surg Venous Lymphat Disord. 2025 Jul;13(4):102240. doi: 10.1016/j.jvsv.2025.102240. Epub 2025 Mar 25. PMID 40147690

Идентификаторы

NCT: NCT07404670 · ChengduUTCM VM

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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