[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06085846":3,"trial-entities:NCT06085846":83,"trial-summary:NCT06085846":88},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":32,"interventions":35,"primary_outcomes":40,"secondary_outcomes":45,"sex":55,"minimum_age":56,"maximum_age":30,"healthy_volunteers":14,"eligibility_criteria":57,"std_ages":66,"locations":69,"central_contacts":79,"overall_officials":80,"references":81,"see_also_links":82},"NCT06085846","AMOAB2301","Real-World Registry - The Vivally® System","ENROLLING_BY_INVITATION","2043-07-01","2024-05","2024-05-29","2023-07-14","Avation Medical, Inc.","INDUSTRY",false,"This is a Real-World Registry Study to collect real-world dosing, utilization, demographic, quality of life, and data from the e-bladder diaries of patients utilizing the Vivally® System. Data points will be drawn from the Avation Medical HIPAA-compliant cloud database including but not limited to:\n\nTherapy compliance and stimulation metrics\n\nDiary entries provided by patients\n\nVarious questionnaires\n\nParticipants have the option to opt out of allowing their data to be part of any publication at any time.","Collect real-world dosing, utilization, demographics and quality of life data from the eDiaries of patients utilizing the Vivally® System.\n\nGather feedback from patients on their experience and satisfaction with the Vivally® System therapy\n\nIdentify trends in dosing, compliance, and therapy parameters in order to optimize the wearable, Vivally® System neuromodulation therapy for participants",[18,19],"Urinary Incontinence","Urinary Urge Incontinence",[21,22,23,24,25,26,27,28],"Neuromodulation","Overactive Bladder","Overactive Bladder Syndrome","Wearable","Non-invasive","Mobile Application","Electronic Bladder Diary","Urgency","OBSERVATIONAL",null,[],{"count":33,"type":34},5000,"ESTIMATED",[36],{"type":37,"name":38,"description":39},"DEVICE","Vivally® System Wearable, Non-Invasive Neuromodulation System, and Mobile Application","Vivally® System Wearable, Non-Invasive Neuromodulation System and Mobile Application to treat patients with the conditions of urinary incontinence and urinary urgency.",[41],{"measure":42,"description":43,"timeFrame":44},"Real-world Usage","Collect real-world dosing, utilization, demographics and quality of life data from the eDiaries of patients utilizing the Vivally® System.","Length of Study, on average 20 years",[46,49,52],{"measure":47,"description":48,"timeFrame":44},"Patient Satisfaction","Gather feedback from patients on their experience and satisfaction with the Vivally® System therapy.",{"measure":50,"description":51,"timeFrame":44},"Prescribing Trends","Identify trends in dosing in order to optimize the wearable, Vivally® System neuromodulation therapy for prescribers. Dosing consists of therapy pulse width parameters (μs) and therapy schedule (sessions completed per week).",{"measure":53,"description":54,"timeFrame":44},"Patient Compliance","Identify trends in patient compliance in order to optimize the wearable, Vivally® System neuromodulation therapy for participants.","ALL","18 Years",{"inclusion":58,"exclusion":61,"raw_text":65},[59,60],"Are an appropriate candidate for the Vivally® System as determined, and prescribed by a licensed clinical professional","Have provided informed consent to have their data included in publications associated with this study",[62,63,64],"Patients with pacemakers of implanted defibrillators","Patients with nerve damage that could impact either transcutaneous tibial nerve stimulation or pelvic floor function","This product is not intended for intra-cardiac or trans-thoracic use","Inclusion Criteria:\n\nTo be eligible for the Real-World Registry Study, Participants must satisfy all of the following criteria:\n\n* Are an appropriate candidate for the Vivally® System as determined, and prescribed by a licensed clinical professional\n* Have provided informed consent to have their data included in publications associated with this study\n\nExclusion Criteria:\n\nWhile it is up to the discretion of the clinician to prescribe the Vivally® System for a specific patient, the Vivally® System is contraindicated for use on patients who have the following history or conditions:\n\n* Patients with pacemakers of implanted defibrillators\n* Patients with nerve damage that could impact either transcutaneous tibial nerve stimulation or pelvic floor function\n* This product is not intended for intra-cardiac or trans-thoracic use\n\nAdditional contraindications, warnings and precautions are listed in the User Guide.",[67,68],"ADULT","OLDER_ADULT",[70],{"facility":71,"city":72,"state":73,"zip":74,"country":75,"geoPoint":76},"Avation Medical","Columbus","Ohio","43201","United States",{"lat":77,"lon":78},39.96118,-82.99879,[],[],[],[],{"nct_id":4,"conditions":84,"biomarkers":87},[85,86],"Overactive bladder syndrome","Urge incontinence of urine",[],{"nct_id":4,"found":14,"summary":30,"prompt_version":30}]