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Safety and Clinical Performance Study of the ARTUS® Artificial Urinary Sphincter (AUS) — DRY  

Stress Urinary Incontinence Clinical Trial

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

Clinical Trial Summary

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® 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 16 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 16 investigational sites). The objectives is to assess safety and clinical performance of the ARTUS® for the treatment of Stress Urinary Incontinence at short and long-term.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04827199
Study type Interventional
Source Myopowers Medical Technologies France SAS
Contact David Phrakorhnkham
Phone +33 (0)4 42 95 12 20
Email david.phrakornkham@affluentmedical.com
Status Not yet recruiting
Phase N/A
Start date December 2022
Completion date December 2034
View Details
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