[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590540":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":30,"responsibleParty":306,"collaborators":20,"id":308,"slug":309,"hasResults":310,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":314,"eligibilityCriteria":315,"healthyVolunteers":310,"sex":316,"minAge":317,"maxAge":20,"enrollmentInfo":318,"targetDuration":20,"studyType":321,"phases":322,"briefSummary":324,"conditions":325,"keywords":327,"overallStatus":33,"whyStopped":20,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":339},{"fullName":5,"class":6},"UroMems SAS","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"UroActive AUS Implant","EXPERIMENTAL","Enrolled subjects who meet study eligibility criteria will proceed to receive the UroActive Artificial Urinary Sphincter (AUS) device",[13],"Device: Artificial Urinary Sphincter (AUS)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Artificial Urinary Sphincter (AUS)","AUS implant",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Roshini Jain","STUDY_DIRECTOR",[26],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","14697669888","roshini.jain@uromems.com",[31,49,62,75,89,102,116,129,143,157,171,181,194,208,222,234,246,258,270,282,294],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"University of California, Los Angeles","RECRUITING","Los Angeles","California","90095","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-118.24368,34.05223,{"lat":43,"lon":42},[46],{"name":47,"role":27,"phone":20,"phoneExt":20,"email":48},"Victor Nitti, MD","VNitti@mednet.ucla.edu",{"facility":50,"status":33,"city":51,"state":35,"zip":52,"country":37,"countryCode":38,"cosmosGeoPoint":53,"geoPoint":57,"contacts":58},"University of California, San Francisco","San Francisco","94153",{"type":40,"coordinates":54},[55,56],-122.41942,37.77493,{"lat":56,"lon":55},[59],{"name":60,"role":27,"phone":20,"phoneExt":20,"email":61},"Benjamin Breyer, MD","Benjamin.Breyer@ucsf.edu",{"facility":63,"status":33,"city":64,"state":35,"zip":65,"country":37,"countryCode":38,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Stanford University","Stanford","94305",{"type":40,"coordinates":67},[68,69],-122.16608,37.42411,{"lat":69,"lon":68},[72],{"name":73,"role":27,"phone":20,"phoneExt":20,"email":74},"Craig Comiter, MD","ccomiter@stanford.edu",{"facility":76,"status":33,"city":77,"state":78,"zip":79,"country":37,"countryCode":38,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Minnesota Urology","Bloomington","Minnesota","55420",{"type":40,"coordinates":81},[82,83],-93.29828,44.8408,{"lat":83,"lon":82},[86],{"name":87,"role":27,"phone":20,"phoneExt":20,"email":88},"Michael Ehlert, MD","MEhlert@mnurology.com",{"facility":90,"status":33,"city":91,"state":78,"zip":92,"country":37,"countryCode":38,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Mayo Clinic","Rochester","55950",{"type":40,"coordinates":94},[95,96],-92.4699,44.02163,{"lat":96,"lon":95},[99],{"name":100,"role":27,"phone":20,"phoneExt":20,"email":101},"Daniel Elliott, MD","elliott.daniel@mayo.edu",{"facility":103,"status":33,"city":104,"state":105,"zip":106,"country":37,"countryCode":38,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Wake Forest University of Health Sciences","Charlotte","North Carolina","28204",{"type":40,"coordinates":108},[109,110],-80.84313,35.22709,{"lat":110,"lon":109},[113],{"name":114,"role":27,"phone":20,"phoneExt":20,"email":115},"Michael Kennelly, MD","Michael.Kennelly@wfusm.edu",{"facility":117,"status":33,"city":118,"state":105,"zip":119,"country":37,"countryCode":38,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Duke University","Durham","27710",{"type":40,"coordinates":121},[122,123],-78.89862,35.99403,{"lat":123,"lon":122},[126],{"name":127,"role":27,"phone":20,"phoneExt":20,"email":128},"Andrew Peterson, MD","drew.peterson@duke.edu",{"facility":130,"status":33,"city":131,"state":132,"zip":133,"country":37,"countryCode":38,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Cleveland Clinic Foundation","Cleveland","Ohio","44106",{"type":40,"coordinates":135},[136,137],-81.69541,41.4995,{"lat":137,"lon":136},[140],{"name":141,"role":27,"phone":20,"phoneExt":20,"email":142},"Kenneth Angermeier, MD","angermk@ccf.org",{"facility":144,"status":33,"city":145,"state":146,"zip":147,"country":37,"countryCode":38,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"Vanderbilt University Medical Center","Nashville","Tennessee","37232",{"type":40,"coordinates":149},[150,151],-86.78444,36.16589,{"lat":151,"lon":150},[154],{"name":155,"role":27,"phone":20,"phoneExt":20,"email":156},"Melissa Kaufman, MD","melissa.kaufman@vumc.org",{"facility":158,"status":33,"city":159,"state":160,"zip":161,"country":37,"countryCode":38,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"Urology Clinics of North Texas","Dallas","Texas","75231",{"type":40,"coordinates":163},[164,165],-96.80667,32.78306,{"lat":165,"lon":164},[168],{"name":169,"role":27,"phone":20,"phoneExt":20,"email":170},"Allen Morey, MD","amorey@urologyclinics.com",{"facility":172,"status":33,"city":159,"state":160,"zip":173,"country":37,"countryCode":38,"cosmosGeoPoint":174,"geoPoint":176,"contacts":177},"University of Texas, Southwestern","75390",{"type":40,"coordinates":175},[164,165],{"lat":165,"lon":164},[178],{"name":179,"role":27,"phone":20,"phoneExt":20,"email":180},"Steven Hudak, MD","Steven.Hudak@UTSouthwestern.edu",{"facility":182,"status":33,"city":183,"state":160,"zip":184,"country":37,"countryCode":38,"cosmosGeoPoint":185,"geoPoint":189,"contacts":190},"University of Texas, MD Anderson","Houston","77030",{"type":40,"coordinates":186},[187,188],-95.36327,29.76328,{"lat":188,"lon":187},[191],{"name":192,"role":27,"phone":20,"phoneExt":20,"email":193},"Lenaine Westney, MD","owestney@mdanderson.org",{"facility":195,"status":33,"city":196,"state":197,"zip":198,"country":37,"countryCode":38,"cosmosGeoPoint":199,"geoPoint":203,"contacts":204},"Urology of Virginia","Virginia Beach","Virginia","23462",{"type":40,"coordinates":200},[201,202],-75.97799,36.85293,{"lat":202,"lon":201},[205],{"name":206,"role":27,"phone":20,"phoneExt":20,"email":207},"Kurt McCammon, MD","kurtmccammon@urologyofva.net",{"facility":209,"status":33,"city":210,"state":20,"zip":20,"country":211,"countryCode":212,"cosmosGeoPoint":213,"geoPoint":217,"contacts":218},"Centre Hospitalier Universitaire de Lille","Lille","France","FR",{"type":40,"coordinates":214},[215,216],3.05512,50.63391,{"lat":216,"lon":215},[219],{"name":220,"role":27,"phone":20,"phoneExt":20,"email":221},"Xavier Biardeau","xavier.biardeau@chu-lille.fr",{"facility":223,"status":33,"city":224,"state":20,"zip":20,"country":211,"countryCode":212,"cosmosGeoPoint":225,"geoPoint":229,"contacts":230},"Hospitals Academics De Marseille Conception","Marseille",{"type":40,"coordinates":226},[227,228],5.38107,43.29695,{"lat":228,"lon":227},[231],{"name":232,"role":27,"phone":20,"phoneExt":20,"email":233},"Gilles Karsenty","gilles.karsenty@ap-hm.fr",{"facility":235,"status":33,"city":236,"state":20,"zip":20,"country":211,"countryCode":212,"cosmosGeoPoint":237,"geoPoint":241,"contacts":242},"Centre Hospitalier Universitaire de Nantes","Nantes",{"type":40,"coordinates":238},[239,240],-1.55336,47.21725,{"lat":240,"lon":239},[243],{"name":244,"role":27,"phone":20,"phoneExt":20,"email":245},"Marie-Aimée Perrouin-Verbe","marieaimee.perrouinverbe@chu-nantes.fr",{"facility":247,"status":33,"city":248,"state":20,"zip":20,"country":211,"countryCode":212,"cosmosGeoPoint":249,"geoPoint":253,"contacts":254},"Groupe Hospitalier Pitié-Salpêtrière","Paris",{"type":40,"coordinates":250},[251,252],2.3488,48.85341,{"lat":252,"lon":251},[255],{"name":256,"role":27,"phone":20,"phoneExt":20,"email":257},"Emmanuel Chartier-Kastler","emmanuel.chartier-kastler@aphp.fr",{"facility":259,"status":33,"city":260,"state":20,"zip":20,"country":211,"countryCode":212,"cosmosGeoPoint":261,"geoPoint":265,"contacts":266},"Centre Hospitalier Univeritaire de Lyon - Hôpital Lyon Sud","Pierre-Bénite",{"type":40,"coordinates":262},[263,264],4.82424,45.70359,{"lat":264,"lon":263},[267],{"name":268,"role":27,"phone":20,"phoneExt":20,"email":269},"Alain Ruffion","alain.ruffion@chu-lyon.fr",{"facility":271,"status":33,"city":272,"state":20,"zip":20,"country":211,"countryCode":212,"cosmosGeoPoint":273,"geoPoint":277,"contacts":278},"Centre Hospitalier Universitaire de Rennes","Rennes",{"type":40,"coordinates":274},[275,276],-1.67431,48.11109,{"lat":276,"lon":275},[279],{"name":280,"role":27,"phone":20,"phoneExt":20,"email":281},"Benoit Peyronnet","benoit.peyronnet@chu-rennes.fr",{"facility":283,"status":33,"city":284,"state":20,"zip":20,"country":211,"countryCode":212,"cosmosGeoPoint":285,"geoPoint":289,"contacts":290},"Centre Hospitalier Universitaire de Rouen","Rouen",{"type":40,"coordinates":286},[287,288],1.09932,49.44313,{"lat":288,"lon":287},[291],{"name":292,"role":27,"phone":20,"phoneExt":20,"email":293},"Jean-Nicolas Cornu","jean-nicolas.cornu@chu-rouen.fr",{"facility":295,"status":33,"city":296,"state":20,"zip":20,"country":211,"countryCode":212,"cosmosGeoPoint":297,"geoPoint":301,"contacts":302},"Hopital Foch","Suresnes",{"type":40,"coordinates":298},[299,300],2.22929,48.87143,{"lat":300,"lon":299},[303],{"name":304,"role":27,"phone":20,"phoneExt":20,"email":305},"Adrien Vidart","a.vidart@hopital-foch.com",{"type":307,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100590540","a-study-to-assess-the-safety-and-effectiveness-of-the-uroactive-artificial-urinary-sphincter-aus-100590540",false,"NCT06968741","A Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter (AUS)","Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter In the treAtment of Stress Urinary Incontinence in Men","SOPHIA2","Key Inclusion Criteria:\n\n* Male subjects aged ≥ 22 years old\n* Able to read, comprehend and willing to sign an informed consent form\n* Primary diagnosis of stress urinary incontinence for at least 6 months, as assessed by the investigator\n* Appropriate surgical candidate with no medical or mental condition that would interfere with study procedures or confound study outcomes as assessed by the investigator\n\nKey Exclusion Criteria:\n\n* Currently enrolled or plans to enroll in another investigational device or clinical drug trial or has completed an investigational study (for urinary incontinence) in the past 3 months prior to informed consent\n* Poor candidate for surgical procedures and\u002For anesthesia, as determined by investigator\n* Currently implanted with an Active Implantable Medical Device (AIMD)\n* Symptoms or diagnosis of urge incontinence or mixed incontinence (MI) with a predominant urgency component, as assessed by the investigator","MALE","22 Years",{"count":319,"type":320},140,"ESTIMATED","INTERVENTIONAL",[323],"NA","Prospective, multicenter, single-arm study",[326],"Stress Urinary Incontinence (SUI)",[328,329],"Stress urinary incontinence","Artificial urinary sphincters","2026-03-26",{"date":332,"type":333},"2026-03-27","ACTUAL",{"date":335,"type":333},"2025-05-19",{"date":337,"type":320},"2031-12",{"name":5,"class":6},21]