Safety and Clinical Performance Study of the ARTUS MONO Artificial Urinary Sphincter (AUS)
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Stress Urinary Incontinence
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: The subjects will be implanted with the ARTUS MONO AUS device and then be followed up for 10 years post-implant, with the primary endpoints measured at 3-month post-device activation visit. As there is no comparator, there is no randomization and no blinding in the study. Clinical performance outcomes will be measured for each subject at baseline (before implantation) and post-implantation.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Only males
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT04827199
- Collaborators
- EVAMED
- Affluent Medical
- Investigators
- Principal Investigator: Roman Zachoval, Pr Thomayerova nemocnice Study Director: Hugues Malandain Myopowers Medical Technologies France SAS