Venous MalformationsNCT07404670
Microwave Ablation for Treatment of Vascular Malformations: Efficacy and Safety
A study testing Microwave Ablation in people with Venous Malformations and Arteriovenous Malformations, run by Chengdu University of Traditional Chinese Medicine.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Venous Malformations, Arteriovenous Malformations, Microwave Ablation
- What is being tested?
- Microwave Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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
- Being tested
- Microwave Ablation
- Keywords
- Microwave Ablation, Vascular Malformations, Venous Malformations, Arteriovenous Malformations, Minimally Invasive Treatment
- Medical subject headings
- Arteriovenous Malformations, Vascular Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microwave AblationDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Microwave Ablation for Vascular Malformations | Experimental | 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. Receives: Device: Microwave Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Preoperative, 1 month, 3 months, 6 months, 12 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 1 month, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Venous MalformationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunshui He, Chengdu University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404670
- Sponsor's protocol ID
- ChengduUTCM VM
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36960915Fang 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.
PubMed 40262997Yin 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.
PubMed 36574903Wang 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.
PubMed 38894863Huang 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.
PubMed 40147690
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective Study to Analyze the Efficacy and Safety of Microwave Ablation for the Treatment of Vascular Malformations
- ClinicalTrials.gov ID
- NCT07404670
- Acronym / sponsor ID
- ChengduUTCM VM
- Conditions
- Venous Malformations, Arteriovenous Malformations, Microwave Ablation, Vascular Malformations
- Keywords
- Microwave Ablation, Vascular Malformations, Venous Malformations, Arteriovenous Malformations, Minimally Invasive Treatment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Chengdu University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microwave Ablation for Vascular Malformations | Experimental | Device: Microwave AblationPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microwave AblationThis 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). | Device | Microwave Ablation for Vascular Malformations |
Primary outcome
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.
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.
2 secondary outcomes
Pain Reduction (Visual Analog Scale - VAS)
Time frame: Preoperative, 1 month, 3 months, 6 months, 12 months
Adverse Events (Incidence and Severity)
Time frame: 1 month, 3 months, 6 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Background: PubMed 36960915Chen 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.
- Results publication: PubMed 40262997Fang 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.
- Results publication: PubMed 36574903Yin 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.
- Results publication: PubMed 38894863Wang 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.
- Results publication: PubMed 40147690Huang 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.
- Individual participant dataSharing planned: No
Related trials for Venous Malformations
Not yet recruiting
A First-In-Man Study to Assess Safety and Efficacy of Ultra High Pressure PTA Balloon ULTRAVIOLET in Treating A-V Fistula Stenosis
Arterio-venous Fistula, Stenosis of Arteriovenous Dialysis Fistula
Enrolling by invitationObservational study
Case-Specific Health Care Professional Clinical Survey for Concerto Versa™ Detachable Coils
Arteriovenous Malformation, Gastrointestinal Bleed
Active, not recruitingObservational study
Merit WRAPSODY™ Endoprosthesis for Treatment of Stenosis or Occlusion (WRAP)
Venous Stenosis, Venous Occlusion
Recruiting
Pelvic Vein Quantitative Flow Characterization Using 2D and 4D Flow MRI
May-Thurner Syndrome, Iliac Venous Compression
RecruitingPhase 3
A Study to Investigate Efficacy and Safety of KP-001 Compared With Placebo in Patients Aged ≥2 Years With Common VM, Common LM, or KTS/CLOVES Syndrome
Venous Malformations, Lymphatic Malformations
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Microwave Ablation in people with Venous Malformations and Arteriovenous Malformations, run by Chengdu University of Traditional Chinese Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chunshui He (18981885601, Chunshuihe@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesion Volume Reduction (time frame: Preoperative, 3 months, 6 months, 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07404670, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.