Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 12:35 AM
NCT ID:
NCT06803667
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Study:
NCT06803667
Study Brief:
Protocol Section:
NCT06803667