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F15 Recharge Free Axonics SNM System Clinical Study | Clinical Trials | Clareo Health

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F15 Recharge Free Axonics SNM System Clinical Study

Prospective, Non-randomized, Multicenter Clinical Evaluation of the Recharge Free Axonics SNM System (Model 4101)

NCT06186765•Axonics, Inc.

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.

Detailed Description

A clinical evaluation to comply with new European Medical Device Regulations (EU MDR) guidelines. Multicenter, prospective, non-randomized, single arm study for OAB and/or FI to assess the safety and performance of the Food and Drug Administration (FDA) approved Axonics recharge free sacral neuromodulation (SNM) System, INS Model 4101. The product is currently marketed under the name F15.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 18 years or older
•2. 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
•3. 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.

Exclusion Criteria

•1. Any significant medical condition that is likely to interfere with procedures, device operation, or likely to confound evaluation of endpoints (exclusion of neurological conditions such as multiple sclerosis)
•2. Any psychiatric or personality disorder that is likely to interfere with procedures at the discretion of the participating physician; this may include poor understanding or compliance with requirements
•3. Previously underwent an external sacral neuromodulation (SNM) trial and was deemed a non-responder or was previously implanted with a sacral neuromodulation device and did not get therapeutic benefit (a non-responder)
•4. History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
•5. A female who is breastfeeding
•6. A female with a positive urine pregnancy test

Locations (16)

Hartford Healthcare

Waterford, Connecticut, United States

Florida Gulf Clinical Research

Bradenton, Florida, United States

East Coast Institute of Research

Jacksonville, Florida, United States

Florida Bladder Institute

Naples, Florida, United States

Atrium Health

Macon, Georgia, United States

Minnesota Urology

Coon Rapids, Minnesota, United States

Adult Pediatric Urology & Urogynecology

Omaha, Nebraska, United States

Columbia University Medical Center

New York, New York, United States

The Oregon Clinic

Portland, Oregon, United States

Southern Shores Urogynecology

Myrtle Beach, South Carolina, United States

Key Dates

Start Date

December 8, 2023

Primary Completion Date

March 1, 2026

Completion Date

March 1, 2027

Last Updated

March 12, 2026

Enrollment

144

ACTUAL participants

Conditions

Urinary Urge Incontinence (UUI)Urinary Frequency (UF)Fecal Incontinence (FI)

Interventions

Axonics SNM System (Model 4101)

DEVICE