Vascular AnomaliesNCT06803667
Radiofrequency Ablation of Vascular Anomalies
A study testing Radiofrequency ablation alone in people with Vascular Anomalies, run by Baylor College of Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Vascular Anomalies
- What is being tested?
- Radiofrequency ablation alone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Use of the Moving Shot Radiofrequency Ablation Technique for the Treatment of Vascular Anomalies
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.
Read more
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.
Read the 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.
- Conditions
- Vascular Anomalies
- Being tested
- Radiofrequency ablation alone
- Keywords
- Venous Malformation, Lymphatic Malformation, Vascular Anomaly, Radiofrequency Ablation
- Medical subject headings
- Vascular Malformations, Lymphatic Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation aloneDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency Ablation Treatment | Experimental | Participants in this single arm study will undergo percutaneous radiofrequency ablation of their vascular anomaly. Receives: Device: Radiofrequency ablation alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From Enrollment to End of Treament at ~6 Months
Secondary outcomes (2)
Society of Interventional Radiology (SIR) Adverse Event Classification System
Procedure Related Adverse Events
Measured: Within 30 Days of Procedure Date
National Cancer Institute Terminology Criteria for Adverse Events
Measured: From Treatment to end of follow-up at ~6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study startMar 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular AnomaliesStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward Gayou, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06803667
- Sponsor's protocol ID
- H-55373
- Status last verified
- Jan 2025
- First submitted
- 27 Jan 2025
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Moving Shot Radiofrequency Ablation Technique for the Treatment of Vascular Anomalies
- ClinicalTrials.gov ID
- NCT06803667
- Acronym / sponsor ID
- H-55373
- Conditions
- Vascular Anomalies
- Keywords
- Venous Malformation, Lymphatic Malformation, Vascular Anomaly, Radiofrequency Ablation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 31 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency Ablation Treatment | Experimental | Device: Radiofrequency ablation aloneParticipants in this single arm study will undergo percutaneous radiofrequency ablation of their vascular anomaly. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- 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
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency ablation aloneRadiofrequency 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. | Device | Radiofrequency Ablation Treatment |
Primary outcome
Pre-procedural ultrasound volume of the lesion of interest, compared with post procedure ultrasound volume of the lesion of interest.
Time frame: 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
2 secondary outcomes
Society of Interventional Radiology (SIR) Adverse Event Classification System
Time frame: Within 30 Days of Procedure Date
National Cancer Institute Terminology Criteria for Adverse Events
Time frame: From Treatment to end of follow-up at ~6 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation alone in people with Vascular Anomalies, run by Baylor College of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edward Gayou, MD (832-822-3800, exgayou@texaschildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-procedural ultrasound volume of the lesion of interest, compared with post procedure ultrasound volume of the lesion of interest. (time frame: From Enrollment to End of Treament at ~6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.