Hancock Jaffe Laboratories announces endpoints for VenoValve study in Colombia
Hancock Jaffe Laboratories announced endpoints for its upcoming VenoValve first-in-human study in Bogota, Colombia. Endpoints for the study will include improvements in reflux time, as well as rVCSS, VAS and VEINES scores, three well known clinical measurements for venous disease. Patients will be monitored at regular intervals during the study with the 90 day and 180 day results being of particular importance to the company and the FDA. Knowledge gained from the Colombian study will be used to make any necessary design modifications to the VenoValves in preparation for the company's U.S. pivotal trial. Duplex scans will be administered to measure reflux time, the duration of reflux in the deep venous system. Reflux occurs when a series of one-way valves in the leg begin to fail, resulting in the backflow of blood. A duplex scan, also known as a doppler test with ultrasound, is a non-invasive evaluation of blood flow through veins and arteries and is the mainstay for evaluating chronic venous insufficiency, or CVI. Improvements in reflux times will be expressed as a percentage of the original duplex measurement. The rVCSS is used to measure changes in venous disease severity and response to treatment and includes ten descriptors or subcategories of venous disease which are rated from 0 to 3 by the clinician. Once an initial baseline rVCSS is established for each patient, changes in rVCSS scores will be tracked and may be expressed as a percentage change from the original or previous scoring. The VAS, or Visual Analogue Scale, is widely used in clinical research to measure intensity and frequency of pain. VEINES is a disease specific, quality of life measurement associated with venous ulcers.