Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
3 participants
INTERVENTIONAL
2018-05-23
2018-09-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Active
ARTUS MONO
ARTUS MONO
Temporarily implant and activation of the medical device
Interventions
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ARTUS MONO
Temporarily implant and activation of the medical device
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
FEMALE
Yes
Sponsors
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Myopowers Medical Technologies France SAS
INDUSTRY
Responsible Party
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Principal Investigators
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Nicolas BARRY DELONGCHAMPS, PR
Role: PRINCIPAL_INVESTIGATOR
Hôpital Cochin
Locations
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Thomayer hospital
Prague, , Czechia
Cochin Hospital
Paris, , France
Countries
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Other Identifiers
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ARTUS00
Identifier Type: -
Identifier Source: org_study_id
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