Radiofrequency Ablation of Vascular Anomalies

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3+
SponsorBaylor College of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Radiofrequency ablation alone

    Device

    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.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Radiofrequency Ablation TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pre-procedural ultrasound volume of the lesion of interest, compared with post procedure ultrasound volume of the lesion of interest.

* 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

Time frame
From Enrollment to End of Treament at ~6 Months

Secondary outcomes

1

Society of Interventional Radiology (SIR) Adverse Event Classification System

Procedure Related Adverse Events

Time frame
Within 30 Days of Procedure Date
2

National Cancer Institute Terminology Criteria for Adverse Events

Time frame
From Treatment to end of follow-up at ~6 Months

Other outcomes

1

Visual Analogue Scale Pain Score

Time frame
Performed prior to procedure and at 2 month and 6 month clinic visits

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: