Key Points
- The Sonablate high-intensity focused ultrasound (HIFU) system is being tested for this new indication.
- Vascular surgeon Naiem Nassiri, MD, will enroll 30 participants in the clinical trial.
The first participant has been treated in a clinical trial assessing the safety of using high-intensity focused ultrasound (HIFU) to treat patients with incompetent veins of the extremities, including vascular malformations.
Incompetent veins – including vascular malformations – involve abnormal flow patterns that can lead to venous insufficiency, a painful condition that affects millions of people in the US. The clinical trial seeks to address deep and superficial venous reflux, varicose veins, venous ulcers, and vascular malformations.
Up to 30 participants with incompetent veins of the extremities will be treated with the Sonablate HIFU system to noninvasively ablate culprit incompetent veins. The Sonablate HIFU system uses extracorporeal imaging to localize and aim the Sonablate HIFU probe. This FDA-approved Investigational Device Exemption (IDE) clinical trial, called HIFIVE (High-Intensity Focused ultrasound for treatment of Incompetent Veins of the Extremity), is led by Naiem Nassiri, MD, a vascular surgeon with The Vascular Care Group (TVCG) in Darien, Connecticut.
Dr. Nassiri and his research Team from The Vascular Breakthroughs, LLC will monitor participants at regular intervals up to 30 days to primarily assess safety of the device, and to secondarily assess for device efficacy in ablating or destroying diseased, incompetent veins.
“This achievement represents the culmination of years of research and development initiated by Dr. Nassiri and Sonablate Corp.,” said Naren Sanghvi, Sonablate’s Chief Scientific Officer. “We are excited to introduce Dr. Nassiri’s innovative solutions to the vascular community, empowering this specialty that can lead to faster recovery times and improved patient safety utilizing the Sonablate image guided HIFU.”
This is the first time that the Sonablate HIFU device is being used to treat vascular disease in humans, but it has had a long history of addressing other diseases. In 2015, it was the first focused ultrasound device to be FDA-cleared in the US for the ablation of prostate tissue, meaning the technology could be used to treat conditions like prostate cancer and benign prostatic hypertrophy. Today, the device is approved for those conditions in more than 50 countries worldwide and has treated thousands of patients with prostate cancer.
For Patients
To learn more about the CVI clinical trial, please visit the clinical trial website or contact the clinical research nurse coordinator at (203) 548-7860, ext. 998, or email mmyslinski@vascularbreakthroughs.com.