Axonics R20 Post-Market Clinical Follow-up (PMCF) Study for the Indication of Fecal Incontinence
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Axonics SNM System INS Model 5101 (R20).
- Who it may be relevant to
- Registry conditions: Fecal Incontinence. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Post-Market Clinical Follow-up Study of the Rechargeable Axonics SNM System INS Model 5101 (R20) for the Indication of Fecal Incontinence (FI)
Overview
Single-Arm, multi-center, prospective, open-label registry study for commercially available rechargeable implantable neurostimulator (INS model 5101); also referred to as R20.
Detailed description
Post-market clinical follow-up for continued assessment of safety and performance of the Axonics INS Model 5101 (R20). The study will include participants with the primary diagnosis of fecal incontinence who are eligible to receive the rechargeable R20 device as per the commercially available IFU.
Interventions
- Device Axonics SNM System INS Model 5101 (R20)
Participants treated with the rechargeable Axonics SNM System Model 5101 also referred to as R20. Commercial devices used in this study are within their intended use as described in each geography's approved instructions for use.
Primary outcome measures
- Performance/effectiveness - Improvement in Quality of Life scoring (FI) [Time frame: 3 months]
- Performance/effectiveness - Improvement in patient satisfaction scoring (FI) [Time frame: 3 months]
Secondary outcome measures (4)
- Performance/effectiveness - Improvement in Quality of Life scoring (FI) [Time frame: 12 months, 24 months]
- Performance/effectiveness - Improvement in Quality of Life scoring (FI) [Time frame: 3 months, 12 months, 24 months]
- Performance/effectiveness - Improvement in patient satisfaction scoring (FI) [Time frame: 12 months]
- Adverse event reporting (Safety) [Time frame: 3 months, 12 months, 24 months]
Eligibility criteria
Inclusion criteria
- 18 years or older
- Primary indication of Fecal Incontinence (FI)
- Willing and capable to provide informed consent and agrees to comply with specified evaluations at selected clinical centers
Exclusion criteria
- Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints (includes neurological conditions such as multiple sclerosis)
- Any psychiatric or personality disorder at the discretion of the study participating physician; this may include poor understanding or compliance with trial requirements
- History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
- A female who is breastfeeding
- A female with a positive urine pregnancy test
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 2 centers
- Columbia University Medical Center — New York
- Houston Colon — Houston
Identifiers
NCT: NCT07499258 · 105-0169