An interventional study of Microwave Ablation in Venous Malformations, Arteriovenous Malformations and Microwave Ablation, sponsored by Chengdu University of Traditional Chinese Medicine. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-02-11.
Sponsored by Chengdu University of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment
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.
92 studies on the registry are indexed under Arteriovenous Malformations; 29 are open to participants now.
This study's planned enrollment of 150 is above the median of 43 across 47 interventional studies indexed under Arteriovenous Malformations.
Browse Arteriovenous Malformations studies →Chengdu University of Traditional Chinese Medicine is the lead sponsor of 59 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Lesion Volume Reduction
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.
Time frame: Preoperative, 3 months, 6 months, 12 months
Swelling and Function Improvement (Venous Malformation Symptom Score - VMSS)
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.
Time frame: Preoperative, 1 month, 3 months, 6 months, 12 months
Pain Reduction (Visual Analog Scale - VAS)
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.
Time frame: Preoperative, 1 month, 3 months, 6 months, 12 months
Adverse Events (Incidence and Severity)
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.
Time frame: 1 month, 3 months, 6 months, 12 months
No study locations are listed for this record.
Plan to share: No
Start is estimated for Mar 2026; primary completion for Mar 2028, 24 months later.
Of 15 interventional studies with no phase under Arteriovenous Malformations, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 77. This study's planned 24 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Chengdu University of Traditional Chinese Medicine