Vascular Insights, a manufacturer of minimally invasive peripheral vascular devices, has initiated a multi-centre dose-finding study of its non-thermal vein ablation ClariVein system, designed for the treatment of venous reflux diseases.
By utilising endovascular technique, the ClariVein system eliminates the risk of nerve damage or parathesia from thermal energy, while removing the need for catheter or guide wire exchanges.
The controlled, randomised trial, which will enrol 600 patients, is designed to identify the ideal sclerosant dosage for great saphenous vein occlusion using the ClariVein system.
The study will be conducted in the Maastricht university hospital and seven additional centres in the Netherlands, according to the company.
Vascular Insights president John Marano said the company is confident that the study will demonstrate that ClariVein is a safe form of treatment for varicose veins and venous reflux.
"This study shows Vascular Insights’ continuing commitment to ensuring the most effective patient outcomes when using the ClariVein system," Marano said.
"We continue to make significant investments in research to generate the data that once again proves the effectiveness of ClariVein."
Maastricht University Medical Centre spokesperson and study principal investigator professor Cees Wittens said; "Because the ClariVein method allows safe treatment of venous segments along nerves, we may significantly improve the optimal treatment of GSV and small saphenous vein (SSV) incompetence by extending the treatment length beyond the traditional approach."