Prospective, Non-randomized, Multicenter Clinical Evaluation of the Recharge Free Axonics SNM System (Model 4101)
Status: Recruiting
Location: See all (16) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Multicenter, prospective, non randomized, single arm evaluation of patients with overactive bladder (OAB) and/or fecal incontinence (FI) employing the Axonics recharge free SNM System.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 18 years or older
• Primary indication of overactive bladder (OAB) (urinary urgency incontinence (UUI)/ urinary frequency (UF)) or fecal incontinence (FI) who are not candidates for, or who have failed conservative treatment
• Willing and capable to provide written informed consent and agrees to comply with specified evaluations at clinical investigational sites and attend all follow-up assessments for up to 1 year.
Locations
United States
Connecticut
Hartford Healthcare
ACTIVE_NOT_RECRUITING
Waterford
Florida
Florida Gulf Clinical Research
ACTIVE_NOT_RECRUITING
Bradenton
East Coast Institute of Research
ACTIVE_NOT_RECRUITING
Jacksonville
Florida Bladder Institute
ACTIVE_NOT_RECRUITING
Naples
Georgia
Atrium Health
ACTIVE_NOT_RECRUITING
Macon
Minnesota
Minnesota Urology
ACTIVE_NOT_RECRUITING
Coon Rapids
Nebraska
Adult Pediatric Urology & Urogynecology
ACTIVE_NOT_RECRUITING
Omaha
New York
Columbia University Medical Center
ACTIVE_NOT_RECRUITING
New York
Oregon
The Oregon Clinic
COMPLETED
Portland
South Carolina
Southern Shores Urogynecology
ACTIVE_NOT_RECRUITING
Myrtle Beach
Texas
Houston Colon
ACTIVE_NOT_RECRUITING
Houston
Other Locations
Netherlands
Erasmus Medical Center
ACTIVE_NOT_RECRUITING
Rotterdam
United Kingdom
Queen Elizabeth Hospital
ACTIVE_NOT_RECRUITING
Birmingham
Bristol Urological Institute
ACTIVE_NOT_RECRUITING
Bristol
University College London Hospital
RECRUITING
London
Northern General Hospital
ACTIVE_NOT_RECRUITING
Sheffield
Contact Information
Primary
Gita Ghadimi, OD
gita.ghadimi@bsci.com
949-396-6322
Backup
Erum Shaikh
erum.shaikh@bsci.com
949-396-6322
Time Frame
Start Date: 2023-12-08
Estimated Completion Date: 2027-03
Participants
Target number of participants: 150
Treatments
Other: Single Arm - product does not have Communauté Européenne (CE) Mark in Europe
Observational
Related Therapeutic Areas
Sponsors
Leads: Axonics, Inc.