MedTrace Logo

ARTUS MONO Artificial Urinary Sphincter

NCT03703843 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2018-10-19

No results posted yet for this study

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

  • Urinary Incontinence,Stress

Interventions

DEVICE

ARTUS MONO

Temporarily implant and activation of the medical device

Sponsors & Collaborators

  • Myopowers Medical Technologies France SAS

    lead INDUSTRY

Principal Investigators

  • Nicolas BARRY DELONGCHAMPS, PR · Hôpital Cochin

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-23
Primary Completion
2018-09-26
Completion
2018-09-26

Countries

  • Czechia
  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03703843 on ClinicalTrials.gov