Radiofrequency Ablation of Vascular Anomalies

Launched by BAYLOR COLLEGE OF MEDICINE · Jan 27, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option called radiofrequency ablation (RFA) for patients with vascular anomalies (VAs), which are abnormal clusters of blood vessels that can cause discomfort or cosmetic concerns. Instead of the standard treatment, sclerotherapy, which involves injecting medication to shrink the VA, this trial will explore whether using heat to treat these anomalies is safer and more effective. Participants will have the chance to choose between the heat treatment and the standard medication option, with both procedures performed under sedation for comfort.

To be eligible for this trial, patients must be over three years old and diagnosed with specific types of slow-flow vascular malformations, like lymphatic or venous malformations. They should be experiencing symptoms that warrant treatment, and their condition must be suitable for the RFA technique. Throughout the process, patients will continue to follow up with the vascular anomalies clinic. While there are some risks involved with both treatment options, including bleeding and infection, the trial aims to offer a potentially better solution to those affected. Participation is completely voluntary, and patients can discuss other treatment options with their doctors if they choose not to participate.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • Patients Over Three Years of Age
• • Radiologic Diagnosis of "Slow Flow" Vascular Malformation, using either Doppler Ultrasound and/or MRI, that is a candidate for sclerotherapy treatment after discussion in multidisciplinary committee
• • Vascular Malformations are a subset of Vascular Anomalies as defined by the International Society For the Study of Vascular Anomalies of 2018 Classification
• Vascular Malformations Include:
• • Capillary Malformations Lymphatic Malformations Venous Malformations Arteriovenous Malformations Arteriovenous Fistula
• • "Slow Flow" Vascular Malformations, as defined by lack of arterial flow on Duplex Ultrasound, will be eligible for enrollment. These include: Lymphatic Malformations Venous Malformations
• • Patient is symptomatic (pain, swelling, functionally limited, or cosmetic concern), and Patient/Guardian desires treatment
• • RFA considered technically feasible and an alternative to targeted sclerotherapy after discussion by multidisciplinary committee
• • Target "Slow Flow" Vascular Malformation is easily visualized/well characterized with ultrasound such that lesion can be easily targeted for RFA using the "moving shot" technique
• • Target Area of "Slow Flow" Vascular Malformation is at least 3 mm below the skin surface
• • Target Area of "Slow Flow" Vascular Malformation is at least 3 mm away from critical neurovascular structures
• • Patient able to undergo General Anesthesia
• • Patient/Guardian Agreeable to RFA in lieu of percutaneous sclerotherapy
• • Patients who have had their vascular anomalies previously treated as well as treatment naive patients are all eligible.
• • Exclusion Criteria
• • History of metallic surgical implants (Pacemaker, ICD, Implantable pain Pump, Spinal cord Stimulator ETC)
• • Pregnant Patients All patients who have begun their menstrual cycle OR are 12 years of age or older will be asked to perform a pregnancy test, either urine or blood per our institutional protocols. If patient/family refuses, signed acknowledgement will be obtained that documents refusal and affirmation of non-pregnant status
• • Patient unable to safely undergo anesthesia