Safety of the Sonablate HIFU System for the Ablation of Incompetent Veins of the Periphery

Launched by SONABLATE · Oct 10, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the safety of a device called Sonablate High Intensity Focused Ultrasound (HIFU) for treating a condition known as Chronic Venous Insufficiency (CVI). CVI can cause problems like varicose veins, leg ulcers, and painful swelling in the legs. The trial is looking for adult patients who have specific venous problems in areas like the legs, abdomen, chest, or back, and whose lesions are not deeper than 4 centimeters from the skin's surface. The goal is to see if this non-invasive treatment can effectively help patients without the need for more invasive procedures like surgery or needles.

To be eligible for the trial, participants must be at least 18 years old and able to give consent for the treatment. They should also be willing to attend follow-up appointments after the procedure. However, some people may not qualify if they have certain health conditions, including issues with their blood vessels or if their lesions are too close to sensitive areas of the body. If chosen to participate, individuals can expect to receive treatment with the Sonablate device and will be monitored closely to ensure their safety throughout the process.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adult patients of age 18 or older with clinical and imaging evidence of venous malformations and/or venous insufficiency of the periphery
• • 2. Lesions no deeper than 4.0cm from the skin surface
• • 3. Lesions appropriate for and patient amenable to HIFU therapy of targeted vascular lesion/structure as determined by the principal operator and investigator
• • 4. Ability to provide treatment consent for Sonablate HIFU energy delivery
• • 5. Ability and willingness to remain compliant with recommended post-op follow-up
• Exclusion Criteria:
• • 1. Patient unable or unwilling to provide consent
• • 2. Patient unable or unwilling to undergo HIFU energy delivery
• • 3. Patient with vascular lesions involving the central nervous system, face, head, and neck, genitalia, visceral or internal organs
• • 4. Patient with known vasculitis or other inflammatory vasculopathies
• • 5. Patients with active or prior history of DVT or PE
• • 6. Any lesion deemed unsafe by the treating surgeon or PI of the study for HIFU at the time of treatment based on clinical assessment, ultrasonographic features and/or probe positioning limitations
• • 7. Subject who has vascular tissue targets lying \<1cm from sensitive structures or large vessels
• • 8. Women who are pregnant or planning to become pregnant prior to procedure or within the 30-day study period, or nursing
• • 9. Vulnerable patients
• • 10. Subject with vessels \>6 mm in diameter within the vascular tissue target