[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631329":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":35,"responsibleParty":56,"collaborators":10,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":10,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":10,"enrollmentInfo":67,"targetDuration":10,"studyType":70,"phases":10,"briefSummary":71,"conditions":72,"keywords":73,"overallStatus":75,"whyStopped":10,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Axonics, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Fecal Incontinence",null,"Participants with the Axonics SNM System Model 5101 and followed up regarding their fecal incontinence symptoms.",[13],"Device: Axonics SNM System INS Model 5101 (R20)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"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.",[9],[21],{"name":22,"affiliation":23,"role":24},"Keith Chapple, MD","Sheffield Teaching Hospitals NHS Foundation Trust","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Caroline Beaudoint","CONTACT","+32 (0) 479 90.41.63","caroline.beaudoint@bsci.com",{"name":32,"role":28,"phone":33,"phoneExt":10,"email":34},"Gita Ghadimi, OD","1-949-981-4366","gita.ghadimi@bsci.com",[36],{"facility":37,"status":10,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Houston Colon","Houston","Texas","77030","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-95.36327,29.76328,{"lat":47,"lon":46},[50,54],{"name":51,"role":28,"phone":52,"phoneExt":10,"email":53},"Jimena Alcocer-Barrios","713-790-0600","jalcocerbarrios@houstoncolon.com",{"name":55,"role":24,"phone":10,"phoneExt":10,"email":10},"Eric M. Haas, MD",{"type":57,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100631329","axonics-r20-post-market-clinical-follow-up-pmcf-study-for-the-indication-of-fecal-incontinence-100631329",false,"NCT07499258","Axonics R20 Post-Market Clinical Follow-up (PMCF) Study for the Indication of Fecal Incontinence","Post-Market Clinical Follow-up Study of the Rechargeable Axonics SNM System INS Model 5101 (R20) for the Indication of Fecal Incontinence (FI)","Inclusion Criteria:\n\n1. 18 years or older\n2. Primary indication of Fecal Incontinence (FI)\n3. Willing and capable to provide informed consent and agrees to comply with specified evaluations at selected clinical centers\n\nExclusion Criteria:\n\n1. 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)\n2. Any psychiatric or personality disorder at the discretion of the study participating physician; this may include poor understanding or compliance with trial requirements\n3. History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone\n4. A female who is breastfeeding\n5. A female with a positive urine pregnancy test","ALL","18 Years",{"count":68,"type":69},55,"ESTIMATED","OBSERVATIONAL","Single-Arm, multi-center, prospective, open-label registry study for commercially available rechargeable implantable neurostimulator (INS model 5101); also referred to as R20.",[9],[9,74],"Sacral Neuromodulation","NOT_YET_RECRUITING","2026-06-11",{"date":78,"type":79},"2026-06-15","ACTUAL",{"date":81,"type":69},"2026-06",{"date":83,"type":69},"2029-12",{"name":5,"class":6},1]