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ARTISTRY: Axonics SacRal NeuromodulaTIon System RegisTRY Study

Sponsor
Axonics Modulation Technologies, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05064384
Collaborator
(none)
300
Enrollment
26
Locations
35
Anticipated Duration (Months)
11.5
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To assess the post-market clinical outcomes with use of the Axonics Sacral Neuromodulation System(s).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Axonics SacRal NeuromodulaTIon System RegisTRY Study : ARTISTRY
    Actual Study Start Date :
    Nov 30, 2020
    Anticipated Primary Completion Date :
    Nov 1, 2023
    Anticipated Study Completion Date :
    Nov 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Therapy Responder Rate [1 year]

      Participants with the External Trial Stimulator and received the Axonics System

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patients scheduled to be trialed with the Axonics External Trial System (ETS), or patients scheduled to receive an Axonics Implantable neurostimulator (INS) or Axonics FS implant

    2. Willing and capable of providing informed consent

    3. Capable of participating in all testing associated with this clinical investigation

    Exclusion Criteria:
    For all indications:

    1. Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints

    2. Any psychiatric or personality disorder at the discretion of the study physician

    3. History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone

    4. A female who is breastfeeding

    5. A female with a positive urine pregnancy test

    For OAB & UR:

    1. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture)

    2. Current symptomatic urinary tract infection (UTI)

    For FI only:
    1. Rectomucosal prolapse or congenital anorectal malformation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arizona State Urological Institute Phoenix Arizona United States 85044
    2 Arkansas Urology Research Center Little Rock Arkansas United States 72210
    3 Sansum Clinic Urology Santa Barbara California United States 93105
    4 Urologic Solutions Fort Myers Florida United States 33908
    5 Florida Urogynecology and Reconstructive Surgery Jacksonville Florida United States 32216
    6 Florida Urology Partners N. Redington Beach Florida United States 33708
    7 Pinellas Urology Saint Petersburg Florida United States 33710
    8 Florida Urology Partners Tampa Florida United States 33606
    9 Georgia Urology McDonough Georgia United States 30253
    10 Northwestern Chicago Illinois United States 60611
    11 LSU Health New Orleans Louisiana United States 70112
    12 Ochsner Health New Orleans Louisiana United States 70121
    13 Chesapeake Urology Hanover Maryland United States 21076
    14 Comprehensive Urology Royal Oak Michigan United States 48073
    15 Adult Pediatric Urology & Urogynecology Omaha Nebraska United States 68114
    16 The Urology Center PC Omaha Nebraska United States 68114
    17 Urologic Research and Consulting Englewood New Jersey United States 07631
    18 Atrium Health Charlotte North Carolina United States 28217
    19 University of Cincinnati Cincinnati Ohio United States 45267-0558
    20 Urologic Specialists Oklahoma Tulsa Oklahoma United States 74146
    21 Institute for Female Pelvic Medicine and Reconstructive Surgery Allentown Pennsylvania United States 18103
    22 The Female Pelvic Health Center Newtown Pennsylvania United States 33606
    23 University of Pittsburgh Pittsburgh Pennsylvania United States 15213
    24 Southern Urogynecology West Columbia South Carolina United States 29169
    25 Center for Pelvic Health Franklin Tennessee United States 37067
    26 University of Alberta Edmonton Alberta Canada

    Sponsors and Collaborators

    • Axonics Modulation Technologies, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Axonics Modulation Technologies, Inc.
    ClinicalTrials.gov Identifier:
    NCT05064384
    Other Study ID Numbers:
    • 105-0076
    First Posted:
    Oct 1, 2021
    Last Update Posted:
    Aug 16, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Axonics Modulation Technologies, Inc.
    Overactive Bladder, bladder control, bowel control
    Additional relevant MeSH terms:
    Fecal Incontinence
    Urinary Retention
    Urinary Incontinence, Urge

    Study Results

    No Results Posted as of Aug 16, 2022