Axonics R20 Post-Market Clinical Follow-up (PMCF) Study for the Indication of Fecal Incontinence

ConditionFecal Incontinence

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorAxonics, Inc.

About this trial

Single-Arm, multi-center, prospective, open-label registry study for commercially available rechargeable implantable neurostimulator (INS model 5101); also referred to as R20.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

Axonics SNM System INS Model 5101 (R20)

Treatment groups

55 Participants

are divided into 1 treatment group

Sponsors and collaborators

Axonics, Inc.

Lead sponsor

Source ClinicalTrials.gov