An interventional study of ARTUS MONO in Urinary Incontinence,Stress, sponsored by Myopowers Medical Technologies France SAS. Completed at 2 sites in 2 countries. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-19.
Sponsored by Myopowers Medical Technologies France SAS · Not applicable, Interventional, and Device feasibility
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.
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's enrollment of 3 is below the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Myopowers Medical Technologies France SAS is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
ARTUS MONO
Device: ARTUS MONO
Temporarily implant and activation of the medical device
Bladder catheterization in presence of ARTUS MONO cuff
Injection then re-aspiration of 50 cc of saline water through 18 Fr Foley catheter
Time frame: Day 0
ARTUS MONO cuff implant
Visual analogic scale (from worst to best imaginable easiness and safety)
Time frame: Day 0
ARTUS MONO cuff activation
Cuff closing to reach 10, 20 and 30% of urethral perimeter reduction
Time frame: Day 0
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Myopowers Medical Technologies France SAS