Safety and Clinical Performance Study of the ARTUS MONO Artificial Urinary Sphincter (AUS)

Safety and Clinical Performance Study of the ARTUS MONO Artificial Urinary Sphincter (AUS) for the Treatment of Stress Urinary Incontinence (SUI) Due to Intrinsic Sphincter Deficiency

This clinical investigation is designed as an interventional, prospective, non-randomized, open-label, single arm, multicentric and international study for obtaining CE marking. The study will be the first performed with the ARTUS MONO AUS medical device aiming to assess safety and performance and will be composed of three phases: pilot phase (with safety analysis on the 10 first included subjects in 3 investigational sites), pivotal phase (in up to 7 investigational sites with a follow-up until the 12-month post-device activation visit, including an interim analysis at 3-month post-device activation visit on performance and safety), long-term phase (with a long-term follow-up until 10 years post implantation in up to 7 investigational sites). The objectives is to assess safety and clinical performance of the ARTUS MONO AUS for the treatment of Stress Urinary Incontinence at short and long-term.

Safety and Clinical Performance Study of the ARTUS MONO Artificial Urinary Sphincter (AUS)

Recruitment

Summary

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