Hancock Jaffe Announces Endpoints for First-in-Human VenoValve Study
January 9, 2019—Hancock Jaffe Laboratories, Inc. (HJLI) announced endpoints for its upcoming VenoValve first-in-human study in Bogota, Colombia. The company recently received approval for the trial from INVIMA, the Colombian regulatory authority. The company is screening patients for the study, which will initially include 5 to 10 patients with severe chronic venous insufficiency.
Endpoints for the study will include improvements in reflux time, as well as three clinical measurements for venous disease: the revised Venous Clinical Severity Score (rVCSS), the Visual Analogue Scale (VAS), and the Venous Insufficiency Epidemiological and Economic Study (VEINES) instrument.
Follow-up will be conducted at 14, 30, 60, 90, and 180 days after implantations of the VenoValves. Duplex scans will be administered to measure reflux time in the deep venous system.
After completion of the 6-month study, the company will seek to present its data at international vascular conferences and publish the data in a peer-reviewed journal.
According to the company, the 90- and 180-day results will be of particular importance to the company and the FDA. HJLI will monitor patients for potentially serious adverse events related to the device. Knowledge gained from the Colombian study will be used to make any necessary design modifications to the VenoValves in preparation for the company’s United States pivotal trial.