F15 Recharge Free Axonics SNM System Clinical Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-08

Study Completion Date

2027-03-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Arm - product does not have Communauté Européenne (CE) Mark in Europe

Observational

Group Type OTHER

Axonics SNM System (Model 4101)

Intervention Type DEVICE

Safety and performance/effectiveness assessment of the recharge free Axonics SNM System (Model 4101 in participants with overactive bladder (OAB) or fecal incontinence (FI).

Interventions

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Axonics SNM System (Model 4101)

Safety and performance/effectiveness assessment of the recharge free Axonics SNM System (Model 4101 in participants with overactive bladder (OAB) or fecal incontinence (FI).

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prof. Bertil Blok, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

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