[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622443":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":10,"responsibleParty":35,"collaborators":10,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":10,"eligibilityCriteria":43,"healthyVolunteers":39,"sex":44,"minAge":45,"maxAge":10,"enrollmentInfo":46,"targetDuration":10,"studyType":49,"phases":10,"briefSummary":50,"conditions":51,"keywords":10,"overallStatus":53,"whyStopped":10,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":10},{"fullName":5,"class":6},"Neuspera Medical, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Neuspera Replacement Cohort",null,"Subjects with previous traditional SNM system and now undergoing implant of the Neuspera SNM System",[13],"Device: Neuspera Implantable Sacral Neuromodulation System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Neuspera Implantable Sacral Neuromodulation System","Stimulation of the Sacral Nerve",[9],[21],{"name":22,"affiliation":23,"role":24},"Kellen Choi, DO","University of Louisville Health System","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Mark Vollmer","CONTACT","408-433-3839","mark.vollmer@neuspera.com",{"name":32,"role":28,"phone":33,"phoneExt":10,"email":34},"Shital Patel","3235281320","shital.patel@neuspera.com",{"type":36,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100622443","freedom-registry---follow-up-revision-experience-and-evaluation-of-device-outcomes-metrics-100622443",false,"NCT07383688","FREEDOM Registry - Follow up Revision Experience and Evaluation of Device Outcomes Metrics","Follow-up Revision Experience and Evaluation of Device Outcomes Metrics in Subjects Receiving Replacement of Traditional Sacral Neuromodulation (SNM) With the Neuspera SNM System","Inclusion Criteria:\n\n1. Currently have a traditional SNM device and has decided to have the device replaced with the Neuspera SNM System OR previously had an existing traditional SNM implant that was completely removed within the last year\n2. Is 22 years of age or older\n3. Had documented at least 50% improvement in UUI episodes on a bladder diary with either a stimulation trial or with their traditional system\n4. Is a good surgical candidate and qualified to receive the Neuspera SNM System per the device labeling\n5. Is capable of participating in all testing and follow-up clinic visits associated with this clinical study.\n\nExclusion Criteria:\n\n1. Has a contraindication for the Neuspera SNM System per the device labeling.\n2. Has plans to enroll or is currently enrolled in another investigational device or drug trial during his\u002Fher participation in this study","ALL","22 Years",{"count":47,"type":48},100,"ESTIMATED","OBSERVATIONAL","Single-arm study where subjects' responses to a questionnaire for the traditional Sacral Neuromodulation (SNM) devices will be compared to the responses regarding the Neuspera SNM System.",[52],"Urinary Urge Incontinence","NOT_YET_RECRUITING","2026-03-03",{"date":56,"type":57},"2026-03-05","ACTUAL",{"date":59,"type":48},"2026-03",{"date":61,"type":48},"2026-10",{"name":5,"class":6}]