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Radiofrequency Ablation of Vascular Anomalies

NCT06803667 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-01-31

No results posted yet for this study

Summary

Vascular Anomalies (VA) are areas of disorganized blood vessel tissue that can appear as lumps or bumps under the skin. Sometimes they can cause you discomfort, or you may not like how they look. One option for treatment is to place a needle through the skin into the VA and inject medicines called sclerosants that can cause them to shrink. This treatment is called sclerotherapy and is the standard of care. While sclerotherapy is safe and effective, other alternatives for treatment exist, such as using heat. Just like with sclerotherapy, a small needle is inserted through the skin into the VA while the doctor watches it using imaging techniques. Once the needle tip is in the right spot, the needle tip delivers heat energy to the VA, causing it to shrink. We believe that using heat to treat VAs may be safer and more effective than using sclerotherapy, and we are asking for your participation in this study to help us determine whether that is correct.

You are being given the option of using heat instead of sclerosant medicines to treat your VA. Regardless of whether you choose targeted heat or sclerosant medicine injection for your treatment, all procedures will be performed under sedation with an anesthesiologist, and you will continue to have appointments with the vascular anomalies clinic after your procedure.

The risks to you if you decide to use heat for treatment of your vascular anomaly are similar to injecting sclerosant medicines, which includes bleeding, infection, and damage to nearby structures.

There is also the additional risk of heating the skin and causing a burn, but the risk of this is low.

Benefits of using heat instead of sclerosant medicine include avoiding sclerosant medicine side effects. Possible benefits include more effective treatment of your vascular anomaly than could be achieved with traditional sclerotherapy.

Participation is entirely voluntary, and if you decide not to use heat for treatment of your VA, you are free to discuss with your doctor alternative treatments like sclerotherapy.

Conditions

  • Vascular Anomalies

Interventions

DEVICE

Radiofrequency ablation alone

Radiofrequency ablation under imaging guidance allows for heating of diseased tissues, and has been used for the treatment of benign and malignant soft tissue masses throughout the body in the United States over the last several decades. Newer radiofrequency ablation devices are smaller and allow for precision temperature regulation; these technologies allow us to safely and precisely deliver heat to diseased tissues while minimizing the heating of nearby healthy tissues. Furthermore, we are able to clearly see these devices under ultrasound, which allows us to move the device in real-time to deliver heat as safely, effectively, and efficiently as possible.

Sponsors & Collaborators

  • Baylor College of Medicine

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-31
Primary Completion
2026-09-30
Completion
2026-09-30
FDA Device
Yes

More Related Trials

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 NCT06803667 on ClinicalTrials.gov