[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sonavex, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":42},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100530740","maturation-of-arteriovenous-fistula-with-automated-sonography-assessments-trial-100530740",false,"NCT06190717","Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial","MAFASA","Inclusion Criteria:\n\n* Males or non-pregnant, non-breastfeeding females ≥ 18 years of age but \\\u003C 85 years of age at the time of informed consent.\n* Subject is able and willing to provide written informed consent prior to receiving any non-standard of care, protocol specific procedures.\n* Subject is willing and capable of complying with all required follow-up visits.\n* Subject and\u002For Care Team agree that the distance and transportation resources from the patient's home to the clinic are reasonable for study participation and compliance.\n* Subject has an estimated life expectancy \\> 18 months.\n* Subject is ambulatory (cane or walker are acceptable).\n* CKD Stage 5 (eGFR less than 10) or ESRD subjects presenting for upper arm autologous arteriovenous fistula creation that is not transposed for hemodialysis access.\n* Subjects who are currently on dialysis through a CVC or who imminently require dialysis (GFR \\\u003C10).\n* Vein diameter ≥ 2.5 mm at the antecubital fossa per vein mapping.\n* Artery diameter ≥ 2.5 mm per vein mapping.\n* Subject is not participating in another investigational clinical trial that has not met its primary end point. Participation in post-market registry is acceptable.\n\nExclusion Criteria:\n\n* CKD Stage 1-4 or subjects that do not require upper arm autologous arteriovenous fistula creation for hemodialysis access.\n* Subject has history of Steal Syndrome.\n* Subject who is immunocompromised or immunosuppressed.\n* Subject has had three previous failed AV fistulae for hemodialysis access.\n* Subjects expecting to undergo major surgery within 60 days from the EchoMark implantation.\n* Known or suspected active infection on the day of the index procedure.\n* Subjects who had infection(s) in the 30-day window prior to EchoMark placement to reduce the likelihood of partially treated infections that can seed the device and fistula.\n* Subjects with diagnosed bleeding disorder, thrombocytopenia (platelet count \\\u003C50,000), hypercoagulability, and history of recurrent deep vein thrombosis not related to AV access.\n* Subjects with active malignancy.\n* Subjects with a history of poor compliance with the dialysis protocol.\n* Subjects with a known or suspected allergy to any of the device materials.\n* Subjects with an existing fistula or graft.\n* Subjects who are anticipated to convert to peritoneal dialysis or undergo a transplant within 6 months.\n* Subjects who are pregnant, planning on becoming pregnant, or are breast feeding.","ALL","18 Years","84 Years",{"count":20,"type":21},304,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a prospective, multi-center, two-arm, randomized trial to quantify the performance of the EchoMark®\u002FEchoSure® System for AVF diagnostic ultrasound when used under a protocol of biweekly use for assessing fistula maturation and reducing time to Clinical Maturation.",[27,28],"Diabetes","End Stage Renal Disease","RECRUITING","2026-04-06",{"date":32,"type":33},"2026-04-13","ACTUAL",{"date":35,"type":33},"2024-02-21",{"date":37,"type":21},"2027-02-01",{"name":39,"class":40},"Sonavex, Inc.","INDUSTRY",21,""]