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Safety and Clinical Performance Study of the ARTUS® Artificial Urinary Sphincter (AUS)

NCT04827199 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2022-09-19

No results posted yet for this study

Summary

This clinical investigation is designed as an interventional, prospective, non-randomized, open-label, single arm, multicentric and international study for obtaining CE marking.

The study will be the first performed with the ARTUS® medical device aiming to assess safety and performance and will be composed of three phases:

* pilot phase (with safety analysis on the 10 first included subjects in 3 investigational sites),
* pivotal phase (in up to 16 investigational sites with a follow-up until the 12-month post-device activation visit, including an interim analysis at 3-month post-device activation visit on performance and safety),
* long-term phase (with a long-term follow-up until 10 years post implantation in up to 16 investigational sites).

The objectives is to assess safety and clinical performance of the ARTUS® for the treatment of Stress Urinary Incontinence at short and long-term.

Conditions

  • Stress Urinary Incontinence

Interventions

DEVICE

Artificial Urinary Sphincter implantation

Device preparation (recharge, settings, pairing) Patient preparation Calibration procedure (to verify the device is in full working prior to implantation) Implantation procedure which includes: * Perineal approach and bulbar urethral dissection * Inguinal approach * Cuff implantation around the urethra * Transmission cable passing * Surgery test procedure * Implantation of the Control Unit * Closure of the inguinal incision * Closure of the perineal incision * "Implant disabled mode" activation

Sponsors & Collaborators

  • EVAMED

    collaborator OTHER

  • Affluent Medical

    collaborator INDUSTRY

  • Myopowers Medical Technologies France SAS

    lead INDUSTRY

Principal Investigators

  • Roman Zachoval, Pr · Thomayerova nemocnice

  • Marion Melot · Myopowers Medical Technologies France SAS

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-31
Primary Completion
2024-04-30
Completion
2034-12-31

Countries

  • Czechia
  • Spain

Study Locations

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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 NCT04827199 on ClinicalTrials.gov