Testing of a sclerosing and embolizing gel for venous disease

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Varicose veins are a part of a spectrum of manifestations of chronic vein disorders that are characterized by the occurence of blood reflux in incompetent veins leading to vein dilatation. Varicose veins are often observed in lower legs due valve failure of the great saphenous vein (GSV). Beside aesthetic concern, edema and pain, varicosities can lead to serious complications such as leg ulcers. The recent estimates of the prevalence of varicosities in the United States range from 15% among men to 28% in women. Varicose veins are also observed in gonadal veins causing severe abdominal pain in women and testicular pain and infertility in men. Gastro-esophageal varices veins are often observed in cirrhosis patient with portal hypertension leading to life threatening bleeding. Different techniques were proposed to treat varicose veins. Mechanical techniques such as ligation, stripping, occlusion with mechanical devices are used to prevent reflux whereas chemical ablation with sclerosant or thermal ablation with laser or radiofrequency probes aim to destroy the wall of the vein. These therapies are often used in combination and the results can be suboptimal leading to recurrence of symptoms and redo procedures leading to increase cost and deterioration of the quality of life. We have developed and patented a sclerosing and embolizing gel at CRCHUM made of chitosan a bio-absorbable gel combined with a sclerosant agent (Sodium Tetradecyl Sulfate). This gel is also visible under X-ray and ultrasound which allows safe delivery under imaging guidance. The gel was licensed to Cook Medical (USA), a world leader company in the development of medical device for interventional radiology. We propose in partnership with Cook Medical and Chitolytic, a canadian company supplying pharmaceutical grade chitosan, to develop a formulation specifically adapted for venous sclerotherapy and test it in a porcine venous model.