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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05064384
Other study ID # 105-0076
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 30, 2020
Est. completion date October 6, 2023

Study information

Verified date April 2024
Source Axonics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 272
Est. completion date October 6, 2023
Est. primary completion date October 6, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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: 6. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture) 7. Current symptomatic urinary tract infection (UTI) For FI only: 8. Rectomucosal prolapse or congenital anorectal malformation

Study Design


Locations

Country Name City State
Canada University of Alberta Edmonton Alberta
United States Institute for Female Pelvic Medicine and Reconstructive Surgery Allentown Pennsylvania
United States Atrium Health Charlotte North Carolina
United States Northwestern Chicago Illinois
United States University of Cincinnati Cincinnati Ohio
United States Urologic Research and Consulting Englewood New Jersey
United States Urologic Solutions Fort Myers Florida
United States Center for Pelvic Health Franklin Tennessee
United States Chesapeake Urology Hanover Maryland
United States Florida Urogynecology and Reconstructive Surgery Jacksonville Florida
United States Arkansas Urology Research Center Little Rock Arkansas
United States Georgia Urology McDonough Georgia
United States Florida Urology Partners N. Redington Beach Florida
United States LSU Health New Orleans Louisiana
United States Ochsner Health New Orleans Louisiana
United States The Female Pelvic Health Center Newtown Pennsylvania
United States Adult Pediatric Urology & Urogynecology Omaha Nebraska
United States The Urology Center PC Omaha Nebraska
United States Arizona State Urological Institute Phoenix Arizona
United States University of Pittsburgh Pittsburgh Pennsylvania
United States Comprehensive Urology Royal Oak Michigan
United States Pinellas Urology Saint Petersburg Florida
United States Sansum Clinic Urology Santa Barbara California
United States Florida Urology Partners Tampa Florida
United States Urologic Specialists Oklahoma Tulsa Oklahoma
United States Southern Urogynecology West Columbia South Carolina

Sponsors (1)

Lead Sponsor Collaborator
Axonics, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Therapy Responder Rate Participants with the External Trial Stimulator and received the Axonics System 1 year
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