[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617392":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":52,"collaborators":20,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":20,"enrollmentInfo":64,"targetDuration":20,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":82,"whyStopped":20,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Mario Negri Institute for Pharmacological Research","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients","EXPERIMENTAL","Patients undergoing HD with a functioning native AVF",[13],"Device: AVF MONITOR",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","AVF MONITOR","Wearable non-invasive device consisting in an electronic platform that can acquire acoustic data by means of an analog microphone.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Giuseppe Remuzzi, M.D.","Istituto Di Ricerche Farmacologiche Mario Negri","STUDY_DIRECTOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Michela Bozzetto","CONTACT","+3903545351","michela.bozzetto@marionegri.it",[33],{"facility":34,"status":20,"city":35,"state":36,"zip":20,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"ASST HPG23 - Unità di Nefrologia","Bergamo","BG","Italy","IT",{"type":40,"coordinates":41},"Point",[42,43],9.66721,45.69601,{"lat":43,"lon":42},[46,50],{"name":47,"role":29,"phone":48,"phoneExt":20,"email":49},"Simona Zerbi, M.D.","+39035267111","szerbi@asst-pg23.it",{"name":47,"role":51,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"type":53,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100617392","avf-monitor-poc-proof-of-concept-study-100617392",false,"NCT07318025","AVF-MONITOR POC Proof-of-concept Study","AVF-MONITOR: a New Wearable Device for Vascular Access Monitoring in Hemodialysis Patients - Proof-of-concept Study","AVFMONITOR POC","Inclusion Criteria:\n\n* Provision of informed consent prior to any study specific procedures.\n* Female and\u002For male aged ≥ 18.\n* Patients undergoing HD with a mature and functioning native AVF.\n\nExclusion Criteria:\n\n* Patients with a history of complications related to the AVF in use.\n* Patients who use a graft or catheter to perform HD.\n* Patients with reduced life expectancy (less than 1 year).","ALL","18 Years",{"count":65,"type":66},6,"ESTIMATED","INTERVENTIONAL",[69],"NA","This is a proof-of-concept single-centre prospective longitudinal interventional study performed in AVF patients under HD treatment at the Nephrology and Dialysis Department of the ASST-Papa Giovanni XXIII (Bergamo, Italy), involving the recording of AVF sounds by the AVF-MONITOR wearable prototype device.\n\nParticipants will undergo a screening and enrollment visit, then follow-up visits for AVF sounds registration will be conducted once a week for all participants, prior to dialysis session, over a period of 8 weeks.",[72],"Hemodyalysis",[74,75,76,77,78,79,80,81],"arteriovenous fistula","hemodialysis","vascular access","monitoring","sound recording","proof-of-concept study","prototype device","vascular stenosis","NOT_YET_RECRUITING","2026-01-12",{"date":85,"type":86},"2026-01-14","ACTUAL",{"date":88,"type":66},"2026-03",{"date":90,"type":66},"2026-09",{"name":5,"class":6},1]