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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03703843
Other study ID # ARTUS00
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 23, 2018
Est. completion date September 26, 2018

Study information

Verified date October 2018
Source Myopowers Medical Technologies France SAS
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 3
Est. completion date September 26, 2018
Est. primary completion date September 26, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Female patients aged = 18 yo

2. BMI > 18,5 and < 35

3. Patient scheduled for an anterior pelvic exenteration with ileal conduit urinary diversion

4. Signed informed consent

Exclusion Criteria:

1. Advanced bladder cancer with bladder neck and/or urethral extension

2. Past pelvic radiation therapy

3. Patient previously treated with an artificial urinary sphincter or other urogenital implant

4. Positive urine culture during the past 2 weeks

5. Indwelling bladder catheter during the past 2 weeks

6. Documented history of sensitivity to silicone

7. History of connectivitis disease

8. Immunosuppressive therapy in the last 3 months

9. Vulnerable subjects

10. Participation in any other clinical investigation

Study Design


Intervention

Device:
ARTUS MONO
Temporarily implant and activation of the medical device

Locations

Country Name City State
Czechia Thomayer hospital Prague
France Cochin Hospital Paris

Sponsors (1)

Lead Sponsor Collaborator
Myopowers Medical Technologies France SAS

Countries where clinical trial is conducted

Czechia,  France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Bladder catheterization in presence of ARTUS MONO cuff Injection then re-aspiration of 50 cc of saline water through 18 Fr Foley catheter Day 0
Secondary ARTUS MONO cuff implant Visual analogic scale (from worst to best imaginable easiness and safety) Day 0
Secondary ARTUS MONO cuff activation Cuff closing to reach 10, 20 and 30% of urethral perimeter reduction Day 0
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