Arteriovenous Malformations, Microwave Ablation, Vascular Malformations, Venous Malformations
Conditions
Keywords
Microwave Ablation, Vascular Malformations, Venous Malformations, Arteriovenous Malformations, Minimally Invasive Treatment
Brief summary
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.
Interventions
DEVICEMicrowave 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).
Sponsors
Chengdu University of Traditional Chinese Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Patients with clinically diagnosed vascular malformations (venous malformations (VM) or arteriovenous malformations (AVM)) confirmed by MRI or ultrasound. 2. Presence of symptomatic lesions (pain, swelling, functional impairment, or ulceration) that require treatment. 3. Lesions that are amenable to microwave ablation based on preoperative clinical and imaging assessment. 4. Ability to provide informed consent or parental consent for minors (if applicable).
Exclusion criteria
1. Capillary malformations or congenital arteriovenous fistula. 2. Lesions that are too close to critical structures (e.g., major blood vessels or nerves) and cannot be safely treated. 3. Pregnancy or breastfeeding. 4. Severe coagulopathy or significant bleeding disorders. 5. Active infection at the treatment site. 6. Patients with severe uncontrolled systemic disease that could interfere with treatment or recovery. 7. Recent treatments (e.g., surgery, sclerotherapy, embolization) for the same lesion within the last 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lesion Volume Reduction | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Reduction (Visual Analog Scale - VAS) | Preoperative, 1 month, 3 months, 6 months, 12 months | This outcome evaluates the improvement in pain levels experienced by participants after undergoing microwave ablation for vascular malformations. The Visual Analog Scale (VAS) will be used to measure pain intensity, with scores recorded before the procedure and at 1 month, 3 months, 6 months, and 12 months post-treatment. A reduction of ≥2 points on the VAS will be considered a significant improvement in pain management. |
| Adverse Events (Incidence and Severity) | 1 month, 3 months, 6 months, 12 months | This outcome monitors the safety of the microwave ablation procedure by tracking any adverse events (AEs) or serious adverse events (SAEs) that occur during or after treatment. Events such as infection, bleeding, nerve damage, and thrombosis will be recorded. Adverse events will be categorized based on severity (mild, moderate, severe) and relatedness to the procedure. The incidence of these events will be evaluated at 1 month, 3 months, 6 months, and 12 months post-procedure. |
Contacts
CONTACTChunshui He
Outcome results
None listed