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Microwave Ablation for Treatment of Vascular Malformations: Efficacy and Safety

NCT07404670 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-02-11

No results posted yet for this study

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.

Conditions

  • Venous Malformations
  • Arteriovenous Malformations
  • Microwave Ablation
  • Vascular Malformations

Interventions

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).

Sponsors & Collaborators

  • Chengdu University of Traditional Chinese Medicine

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2028-03-01
Completion
2028-03-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07404670 on ClinicalTrials.gov