Trials / Completed
CompletedNCT03703843
ARTUS MONO Artificial Urinary Sphincter
Feasibility of ARTUS MONO Artificial Urinary Sphincter Implant in Women
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- Myopowers Medical Technologies France SAS · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The ARTUS MONO implant is an active implantable medical device (AIMD) that assist the urethral sphincter function of female patients suffering from moderate to severe urinary incontinence, by remotely opening and closing a cuff placed around the bladder neck. The purpose of this clinical investigation is to evaluate the feasibility of implantation of the device, its safety and its efficacy, when temporarily implanted in female patients scheduled for anterior pelvic exenteration for bladder cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ARTUS MONO | Temporarily implant and activation of the medical device |
Timeline
- Start date
- 2018-05-23
- Primary completion
- 2018-09-26
- Completion
- 2018-09-26
- First posted
- 2018-10-12
- Last updated
- 2018-10-19
Locations
2 sites across 2 countries: Czechia, France
Source: ClinicalTrials.gov record NCT03703843. Inclusion in this directory is not an endorsement.