Radiofrequency Ablation of Vascular Anomalies

NCT06803667 | Not Yet Recruiting FDA Device

• 1 other identifier: H-55373
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Vascular Anomalies

Keywords

Venous Malformation; Lymphatic Malformation; Vascular Anomaly; Radiofrequency Ablation

Outcome Measures

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

  From Enrollment to End of Treament at ~6 Months

Secondary Outcomes (2)

• Society of Interventional Radiology (SIR) Adverse Event Classification System

  Within 30 Days of Procedure Date

• National Cancer Institute Terminology Criteria for Adverse Events

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

Other Outcomes (1)

• Visual Analogue Scale Pain Score

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

Study Arms (1)

Radiofrequency Ablation Treatment

EXPERIMENTAL

Participants in this single arm study will undergo percutaneous radiofrequency ablation of their vascular anomaly.

Device: Radiofrequency ablation alone

Interventions

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.

Radiofrequency Ablation Treatment

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead

MeSH Terms

Conditions

Vascular Malformations; Lymphatic Abnormalities

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

Edward Gayou, MD

CONTACT

832-822-3800; exgayou@texaschildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Edward Gayou MD

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: January 31, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 31, 2025

Record last verified: 2025-01