Radiofrequency Ablation of Vascular Anomalies

Not Applicable

Not yet recruiting

• Conditions: Vascular Anomalies

• Registration Number: NCT06803667
• Lead Sponsor: Baylor College of Medicine

Brief 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.

Detailed Description

Patients who seek care for their vascular anomalies at the Texas Children's Vascular Anomalies (VA) clinic will be potentially eligible for this study. Patients who are diagnosed with a VA and interested in having it treated will be discussed among the vascular anomalies clinic physicians. If vascular anomalies clinic physicians feel that heating the vascular anomaly using a radiofrequency needle is a good option, you will then be offered heat ablation as an alternative to sclerotherapy. After a risks and benefits discussion, if you are interested in having your vascular anomaly treated with heat instead of sclerotherapy, you will be enrolled. You will be asked to rate your pain on a scale of 1-10 when your pain is at its worst, 1 being no pain at all, and 10 being the worst pain imaginable.

Once enrolled, you will be scheduled for your procedure date. Procedures are typically scheduled in the morning, and you will be asked to fast after midnight. When you arrive for your procedure, you will be evaluated by the anesthesia team, and an appropriate sedation plan will be determined. Once all safety checks are performed, you will be taken back into one of the interventional radiology suites, and you will receive anesthesia medicine. Once the medicine has been administered, you will be positioned on the interventional radiology table. A plastic pad will be carefully placed on each of your thighs. These are called grounding pads and allow for the radiofrequency ablation probe to generate heat energy when activated.

Once the pads are safely secured on the thighs, your skin directly above the vascular anomaly will be prepped with cleaning solution, and sterile drapes will be placed to reduce the risk of infection. Once the final safety check is performed, the procedure will begin. Using a special imaging tool called ultrasound that uses sound waves to allow us to see structures under the skin, the operator will identify the vascular anomaly. Then, while watching under ultrasound, the ablation needle will carefully be inserted into the vascular anomaly. Once the operator is satisfied with the position of the radiofrequency ablation needle, the device will be turned on, and heat will be delivered to the vascular anomaly. The needle will be moved slightly to ensure that heat reaches all parts of the vascular anomaly. We always watch the ablation needle whenever it is actively delivering heat or when we are moving it to reduce the risk of heating other areas near the vascular anomaly. Once the vascular anomaly has been sufficiently heated, the needle will be removed, and a small bandage will be placed. You will then be taken to the recovery area, where you will be allowed to go home after the effects of the anesthesia have ended.

You will meet with the physician who performed the procedure 1 week postoperatively for a virtual clinic visit for a check-in. If all is well at this virtual clinic appointment, you will then return in person 8 weeks after your treatment date. During this clinic visit, you will be evaluated by vascular anomalies clinic physicians, and you will be asked to rate your pain on a scale of 1-10, as described earlier. In addition to that, you will have an ultrasound performed on the vascular anomaly, so we can assess the effects of the heat and compare it to before the procedure. You will have another in person vascular anomalies clinic at 6 months following the treatment date, which will be identical to the 2 month clinic visit. After this 6 month clinic visit, your participation will be concluded. In total, we expect your participation in this study to last about 6 months, measured from enrollment after first clinic visit, to the 3rd and final 6 month postoperative clinic visit. However, it may be slightly longer than this depending on the scheduling of the ablation procedure and subsequent clinic visits. Participation in this trial is entirely voluntary, you may choose to stop participating at any time.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-27
• Study First Submitted QC: 2025-01-27
• Last Update Submitted: 2025-01-27
• Study First Posted: 2025-01-31
• Last Update Posted: 2025-01-31
• Study Start: 2025-03
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pre-procedural ultrasound volume of the lesion of interest, compared with post procedure ultrasound volume of the lesion of interest.	From Enrollment to End of Treament at ~6 Months	* Pre-procedural ultrasound volume of the lesion of interest, compared with post procedure ultrasound volume of the lesion of interest.; * This will be measured in cm3 on ultrasound (LxWxHx.05).; * Pre-procedure will be measured prior to ablation.; * Post Procedure measurements will occur at 2 month and 6 month postoperative clinic visits.; * Volume will be summarized and reported in cubic centimeters

Secondary Outcome Measures

Name	Time	Method
Society of Interventional Radiology (SIR) Adverse Event Classification System	Within 30 Days of Procedure Date	Procedure Related Adverse Events
National Cancer Institute Terminology Criteria for Adverse Events	From Treatment to end of follow-up at ~6 Months