[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658584":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":41,"studyPopulation":33,"armGroups":42,"interventions":53,"overallOfficials":33,"centralContacts":64,"locations":70,"responsibleParty":109,"collaborators":33,"id":111,"slug":112,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":113,"sex":119,"minAge":120,"maxAge":33,"enrollmentInfo":121,"targetDuration":33,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":132,"overallStatus":134,"whyStopped":33,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"X9, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":33},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Cannulation Clinical Success Score (CCSS)","Co-primary endpoint. CCSS is achieved when haemodialysis is successfully started without additional needle puncture, needle repositioning or redirection, or infiltration. For each participant, the number of sessions achieving CCSS (out of three per treatment condition) is compared between the investigational device and standard of care (SOC). The study meets its primary effectiveness criterion only if both co-primary endpoints (CCSS and pain) are met.","At each of six cannulation sessions over 2 weeks",{"measure":14,"description":15,"timeFrame":12},"Mean Insertion Pain (0-10 Numeric Rating Scale)","Co-primary endpoint. Participants rate pain for each needle insertion on a 0-10 scale (0 = no pain, 10 = worst pain possible). Each participant's mean pain score with the investigational device is compared with their mean pain score with SOC. The study meets its primary effectiveness criterion only if both co-primary endpoints (CCSS and pain) are met.",{"measure":17,"description":18,"timeFrame":19},"Rate of serious adverse events (SAEs) related to the investigational device or procedure during the clinical investigation.","Each participant will be a safety endpoint failure if the participant has SAEs related to the investigational device or procedure, otherwise the participant will be a primary safety endpoint success.","At each of three investigational device cannulation sessions over 1 week",[21,24,27,30],{"measure":22,"description":23,"timeFrame":12},"Cannulation Clinical Success Score (CCSS): Superiority","Superiority of the investigational device to SOC for the number of sessions achieving CCSS. Tested only if both co-primary endpoints (CCSS and pain) are met. Not required for the primary effectiveness endpoint.",{"measure":25,"description":26,"timeFrame":12},"Technical insertion success with blood flashback","The proportion of sessions in each group with successful blood flashback from both needles.",{"measure":28,"description":29,"timeFrame":12},"Successful initiation of hemodialysis","The proportion of sessions in each group with successful initiation of hemodialysis.",{"measure":31,"description":32,"timeFrame":12},"Successful completion of hemodialysis","The proportion of sessions in each group with successful completion of hemodialysis.",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":37,"primaryPurpose":38,"observationalModel":33,"timePerspective":33,"maskingInfo":39},"RANDOMIZED","CROSSOVER","Participants serve as their own control.","TREATMENT",{"masking":40,"maskingDescription":33,"whoMasked":33},"NONE","This is a prospective, multicenter, randomized treatment sequence, crossover clinical investigation at up to three sites in Australia and New Zealand. Up to 35 participants will complete three sessions under each treatment condition (investigational device and SOC).\n\nThe investigational device is designed to supplement the traditional \"look, listen, and feel\" approach and to replace \"blind\" needle insertion for cannulation. The device is inserted under operator control using ultrasound guidance, with the aim of aligning the needle tip with the center of the target vessel and reducing reliance on blind cannulation.",[43,48],{"label":44,"type":45,"description":33,"interventionNames":46},"Standard of Care Cannulation","ACTIVE_COMPARATOR",[47],"Other: Needle Placement with SOC",{"label":49,"type":50,"description":33,"interventionNames":51},"Investigational Device Cannulation","EXPERIMENTAL",[52],"Device: Needle placement with the Investigational Device",[54,59],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":33},"DEVICE","Needle placement with the Investigational Device","Dialysis cannulation needle placement with the investigational device",[49],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":33},"OTHER","Needle Placement with SOC","Dialysis cannulation needle placement per SOC",[44],[65],{"name":66,"role":67,"phone":68,"phoneExt":33,"email":69},"Rachel Walsh","CONTACT","9256839456","rwalsh@x9med.com",[71,87,97],{"facility":72,"status":33,"city":73,"state":33,"zip":33,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"Barwon Health","Geelong","Australia","AU",{"type":77,"coordinates":78},"Point",[79,80],144.36069,-38.14711,{"lat":80,"lon":79},[83],{"name":84,"role":67,"phone":85,"phoneExt":33,"email":86},"Suzannah Barker","+61 2 8317-5460","suzannah@mobius-cro.com",{"facility":88,"status":33,"city":89,"state":33,"zip":33,"country":74,"countryCode":75,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"St. Vincent's Hospital","Melbourne",{"type":77,"coordinates":91},[92,93],144.96332,-37.814,{"lat":93,"lon":92},[96],{"name":84,"role":67,"phone":85,"phoneExt":33,"email":86},{"facility":98,"status":33,"city":99,"state":33,"zip":33,"country":100,"countryCode":101,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Waikato Hospital","Hamilton","New Zealand","NZ",{"type":77,"coordinates":103},[104,105],175.28333,-37.78333,{"lat":105,"lon":104},[108],{"name":84,"role":67,"phone":85,"phoneExt":33,"email":86},{"type":110,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100658584","a-study-of-a-device-that-helps-place-dialysis-needles-100658584",false,"NCT07856095","A Study of a Device That Helps Place Dialysis Needles","Prospective Evaluation of Device-Assisted Needle Insertion for Vascular Access Study","VA-ASSIST","Inclusion Criteria:\n\n1. Males or non-pregnant, non-breastfeeding females ≥ 21 years of age\n2. Receiving facility-based (in-center) haemodialysis\n3. Presence of an arteriovenous fistula (AVF) or arteriovenous graft (AVG) in the arm.\n4. AVF\u002FAVG is actively used for haemodialysis treatment.\n5. AVF\u002FAVG diameter between 6 mm and 12 mm, confirmed by ultrasound.\n6. AVF\u002FAVG is ≤6 mm below the surface of the skin, confirmed by ultrasound.\n7. Able to complete the study questionnaires.\n8. Able and willing to provide written informed consent.\n\nExclusion Criteria:\n\n1. Presence of known stents in the cannulation zone of the AVF\u002FAVG access site\n2. Presence of a condition or impediment that may interfere with ultrasound imaging","ALL","21 Years",{"count":122,"type":123},35,"ESTIMATED","INTERVENTIONAL",[126],"NA","The purpose of this study is to evaluate the safety and effectiveness of the X9 Ultrasound System with Power-Assisted Needle Insertion, an investigational device, compared with standard of care (SOC) cannulation for placing haemodialysis needles in an arteriovenous fistula (AVF) or arteriovenous graft (AVG).",[129,130,131],"Dialysis","Cannulation","Vascular Access",[133],"dialysis cannulation","NOT_YET_RECRUITING","2026-09-27",{"date":137,"type":138},"2026-10-02","ACTUAL",{"date":140,"type":123},"2026-12",{"date":142,"type":123},"2027-02",{"name":5,"class":6},3]