The Hancock Jaffe Surgical Antireflux Venous Valve Endoprosthesis (SAVVE) Study Trial

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The Hancock Jaffe Surgical Antireflux Venous Valve Endoprosthesis (SAVVE) Study Trial

Brief description of study

To assess the safety and effectiveness of the Hancock Jaffe VenoValve for the treatment of patients with deep venous valvular insufficiency A prospective, non-blinded, single-arm multi-center pivotal study of the Hancock Jaffe VenoValve. All patients will receive optimized care (e.g., appropriate medications, compression therapy) throughout the study. The study will be conducted in accordance with the 2020 Standard ISO 14155 (Clinical investigation of medical devices for human patients - Good clinical practice), and other regulatory and legal requirements.

Clinical Study Identifier: s21-00188

Principal Investigator: Mikel Sadek.

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