Microwave Ablation for Treatment of Vascular Malformations: Efficacy and Safety

February 5, 2026 updated by: Chunshui He, Chengdu University of Traditional Chinese Medicine

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lesion Volume Reduction
Time Frame: 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.
Preoperative, 3 months, 6 months, 12 months
Swelling and Function Improvement (Venous Malformation Symptom Score - VMSS)
Time Frame: 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.
Preoperative, 1 month, 3 months, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Reduction (Visual Analog Scale - VAS)
Time Frame: 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.
Preoperative, 1 month, 3 months, 6 months, 12 months
Adverse Events (Incidence and Severity)
Time Frame: 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.
1 month, 3 months, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chengdu University of Traditional Chinese Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

February 5, 2026

First Submitted That Met QC Criteria

February 5, 2026

First Posted (Actual)

February 11, 2026

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ChengduUTCM VM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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