[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06190717":3,"trial-entities:NCT06190717":392,"trial-summary:NCT06190717":397},{"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":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":40,"secondary_outcomes":48,"sex":79,"minimum_age":80,"maximum_age":81,"healthy_volunteers":82,"eligibility_criteria":83,"std_ages":112,"locations":115,"central_contacts":384,"overall_officials":389,"references":390,"see_also_links":391},"NCT06190717","MAFASA-2023","Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial","RECRUITING","2027-02-01","2025-06","2026-04-13","2024-02-21","Sonavex, Inc.","INDUSTRY",true,"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.",null,[18,19],"Diabetes","End Stage Renal Disease",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},304,"ESTIMATED",[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DEVICE","EchoMark\u002FEchoSure","Subjects assigned to the Diagnostic Arm will have the EchoMark implanted at the time of AVF creation. The subject will return every 2 weeks for a follow-up assessment to include an EchoSure scan until fistula maturation and\u002For permanent access use is achieved. The EchoSure scans are to be reviewed by the investigator(s) or delegated study staff and aid in the determination when a further assessment, including a physical exam, is required to determine cannulation clearance or if an intervention(s) may be required to prevent failure of fistula maturation. All physical exams will include assessing the fistula for bruit and thrill. The subject's medical history will be reviewed at each visit and will include all interventions, cannulation attempts, and adverse event reporting.",[34],"Diagnostic Arm",{"type":36,"name":37,"description":38,"armGroupLabels":39},"PROCEDURE","Standard of Care","Subjects are assessed using standard of care per KDOQI guidelines, which includes a physical exam at the 2-week follow-up visit and at the 4-6-week follow-up visit. All follow-up visits will include an assessment of adverse events and medical history review to include all interventions, cannulation attempts, and laboratory results. If evaluation yields an abnormal finding, subjects will undergo a Duplex ultrasound assessment and treatment under the institution's standard of care. All SOC Arm subjects will be followed per the institution's standard of care until fistula maturation occurs and\u002For permanent access use is achieved but no more frequently than once per month.",[37],[41,45],{"measure":42,"description":43,"timeFrame":44},"Primary Safety Endpoint","Freedom from the following through 6 months as adjudicated by the CEC:\n\n1. Clinically significant misplacement or migration of the EchoMark implant.\n2. Vessel or tissue injury caused by the EchoMark implant procedure of the implant over time, requiring surgical intervention.\n3. Infection of tissues surrounding the EchoMark implant requiring IV\u002F\n4. Complication requiring explantation of the EchoMark implant.","6 months",{"measure":46,"description":47,"timeFrame":44},"Primary Effectiveness Endpoint","Time to clinical maturation",[49,53,56,59,63,66,69,72,75],{"measure":50,"description":51,"timeFrame":52},"Difference between EchoSure and Duplex Flow Measurements","Difference between log10-transformed EchoSure and Duplex flow measurements of blood flow for assessment of measurement agreement in the diagnostic arm.","6 Months",{"measure":54,"description":55,"timeFrame":52},"EchoSure Depth Comparison","Difference between EchoSure and CoreLab measurements of depth for assessment of measurement agreement in the diagnostic arm.",{"measure":57,"description":58,"timeFrame":52},"EchoSure Diameter Comparison","Difference between EchoSure and CoreLab measurement of diameter for assessment of measurement agreement in the diagnostic arm.",{"measure":60,"description":61,"timeFrame":62},"EchoMark\u002FEchoSure System Technical Success","Technical Success defined as the successful implantation of the EchoMark implant and the ability to complete each scan to determine the blood flow, diameter, and depth measurements at the EchoMark using the EchoSure diagnostic ultrasound system from baseline to Clinical Maturation, fistula failure, or 4 months, whichever is sooner.","4 Months",{"measure":64,"description":65,"timeFrame":52},"CVC Removal","Time to CVC removal by subject group",{"measure":67,"description":68,"timeFrame":52},"Rate of Hospitalization","Rate of hospitalization(s) by subject group from baseline to Clinical Maturation.",{"measure":70,"description":71,"timeFrame":52},"AV Fistula Maturation Rate","Percent of AVFs created that mature by 180 days by subject group.",{"measure":73,"description":74,"timeFrame":52},"Total Cost of Care","Total cost of care, defined by National average Medicare payment rate (facility and professional fees) for procedures and care provided to subject by subject group from baseline to Clinical Maturation.",{"measure":76,"description":77,"timeFrame":78},"Freedom from Events through 30 and 90 Days","Freedom from the following through 30 and 90 days from the baseline procedure as adjudicated by the CEC:\n\n1. Clinically significant misplacement or migration of the EchoMark implant.\n2. Vessel or tissue injury caused by the EchoMark implant procedure of the implant over time, requiring surgical intervention.\n3. Infection of tissues surrounding the EchoMark implant requiring IV antibiotic treatment.\n4. Complication requiring explantation of the EchoMark implant.","30 Days and 90 Days","ALL","18 Years","84 Years",false,{"inclusion":84,"exclusion":96,"raw_text":111},[85,86,87,88,89,90,91,92,93,94,95],"Males or non-pregnant, non-breastfeeding females ≥ 18 years of age but \\\u003C 85 years of age at the time of informed consent.","Subject is able and willing to provide written informed consent prior to receiving any non-standard of care, protocol specific procedures.","Subject is willing and capable of complying with all required follow-up visits.","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.","Subject has an estimated life expectancy \\> 18 months.","Subject is ambulatory (cane or walker are acceptable).","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.","Subjects who are currently on dialysis through a CVC or who imminently require dialysis (GFR \\\u003C10).","Vein diameter ≥ 2.5 mm at the antecubital fossa per vein mapping.","Artery diameter ≥ 2.5 mm per vein mapping.","Subject is not participating in another investigational clinical trial that has not met its primary end point. Participation in post-market registry is acceptable.",[97,98,99,100,101,102,103,104,105,106,107,108,109,110],"CKD Stage 1-4 or subjects that do not require upper arm autologous arteriovenous fistula creation for hemodialysis access.","Subject has history of Steal Syndrome.","Subject who is immunocompromised or immunosuppressed.","Subject has had three previous failed AV fistulae for hemodialysis access.","Subjects expecting to undergo major surgery within 60 days from the EchoMark implantation.","Known or suspected active infection on the day of the index procedure.","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.","Subjects with diagnosed bleeding disorder, thrombocytopenia (platelet count \\\u003C50,000), hypercoagulability, and history of recurrent deep vein thrombosis not related to AV access.","Subjects with active malignancy.","Subjects with a history of poor compliance with the dialysis protocol.","Subjects with a known or suspected allergy to any of the device materials.","Subjects with an existing fistula or graft.","Subjects who are anticipated to convert to peritoneal dialysis or undergo a transplant within 6 months.","Subjects who are pregnant, planning on becoming pregnant, or are breast feeding.","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.",[113,114],"ADULT","OLDER_ADULT",[116,132,145,154,168,181,194,209,222,235,248,261,274,287,299,312,320,333,345,360,372],{"facility":117,"status":7,"city":118,"state":119,"zip":120,"country":121,"contacts":122,"geoPoint":129},"Trinity Research Group","Dothan","Alabama","36301","United States",[123,126],{"name":124,"role":125},"E Ivey","CONTACT",{"name":127,"role":128},"Jason Beaver, MD","PRINCIPAL_INVESTIGATOR",{"lat":130,"lon":131},31.22323,-85.39049,{"facility":133,"status":7,"city":134,"state":135,"zip":136,"country":121,"contacts":137,"geoPoint":142},"Southwest Kidney Institute","Phoenix","Arizona","85004",[138,140],{"name":139,"role":125},"J Rodriguez",{"name":141,"role":128},"Umar Waheed, MD",{"lat":143,"lon":144},33.44838,-112.07404,{"facility":146,"status":7,"city":134,"state":135,"zip":147,"country":121,"contacts":148,"geoPoint":153},"AKDHC Medical Research Services","85012",[149,151],{"name":150,"role":125},"A Zabala",{"name":152,"role":128},"S Wang, MD",{"lat":143,"lon":144},{"facility":155,"status":7,"city":156,"state":135,"zip":157,"country":121,"contacts":158,"geoPoint":165},"AKDHC Center Tucson","Tucson","85754",[159,163],{"name":160,"role":125,"phone":161,"email":162},"A Munoz","520-622-3569","amgallego@akdhc.com",{"name":164,"role":128},"Z Yang, MD",{"lat":166,"lon":167},32.22174,-110.92648,{"facility":169,"status":7,"city":170,"state":171,"zip":172,"country":121,"contacts":173,"geoPoint":178},"Orlando Health Heart and Vascular Institute","Orlando","Florida","32806",[174,176],{"name":175,"role":125},"G. Nyo",{"name":177,"role":128},"G Castaneda, MD",{"lat":179,"lon":180},28.53834,-81.37924,{"facility":182,"status":7,"city":183,"state":184,"zip":185,"country":121,"contacts":186,"geoPoint":191},"Northwestern University","Chicago","Illinois","60611",[187,189],{"name":188,"role":125},"J Kasperek",{"name":190,"role":128},"V Rohan, MD",{"lat":192,"lon":193},41.85003,-87.65005,{"facility":195,"status":7,"city":196,"state":197,"zip":198,"country":121,"contacts":199,"geoPoint":206},"Kansas Nephrology Research Institute","Wichita","Kansas","67214",[200,204],{"name":201,"role":125,"phone":202,"email":203},"A Anderson","316-262-2045","aanderson@researchmgmt.com",{"name":205,"role":128},"Dennis Ross, MD",{"lat":207,"lon":208},37.69224,-97.33754,{"facility":210,"status":7,"city":211,"state":212,"zip":213,"country":121,"contacts":214,"geoPoint":219},"Boston Medical Center","Boston","Massachusetts","02118",[215,217],{"name":216,"role":125},"C Roddy",{"name":218,"role":128},"J Siracuse, MD",{"lat":220,"lon":221},42.35843,-71.05977,{"facility":223,"status":7,"city":224,"state":225,"zip":226,"country":121,"contacts":227,"geoPoint":232},"MSU Health Care Heart and Vascular","Lansing","Michigan","48910",[228,230],{"name":229,"role":125},"A Burghardt",{"name":231,"role":128},"Jordan Knepper, MD",{"lat":233,"lon":234},42.73253,-84.55553,{"facility":236,"status":7,"city":237,"state":238,"zip":239,"country":121,"contacts":240,"geoPoint":245},"Capital Medical Center","Pennington","New Jersey","08534",[241,243],{"name":242,"role":125},"L Gant",{"name":244,"role":128},"Christine Lotto, MD",{"lat":246,"lon":247},40.32844,-74.79072,{"facility":249,"status":7,"city":250,"state":251,"zip":252,"country":121,"contacts":253,"geoPoint":258},"Northwell Health","New Hyde Park","New York","11042",[254,256],{"name":255,"role":125},"Virginia Wairimu",{"name":257,"role":128},"Yana Etkin, MD",{"lat":259,"lon":260},40.7351,-73.68791,{"facility":262,"status":7,"city":263,"state":264,"zip":265,"country":121,"contacts":266,"geoPoint":271},"Atrium Health","Concord","North Carolina","28025",[267,269],{"name":268,"role":125},"G Brown",{"name":270,"role":128},"Christopher Mitromaras, MD",{"lat":272,"lon":273},35.40888,-80.58158,{"facility":275,"status":7,"city":276,"state":277,"zip":278,"country":121,"contacts":279,"geoPoint":284},"Prisma Health","Greenville","South Carolina","29605",[280,282],{"name":281,"role":125},"M Salle",{"name":283,"role":128},"Sagar Gandhi, MD",{"lat":285,"lon":286},34.85262,-82.39401,{"facility":288,"status":7,"city":289,"state":277,"zip":290,"country":121,"contacts":291,"geoPoint":296},"Medical University of South Carolina Health Orangeburg","Orangeburg","29118",[292,294],{"name":293,"role":125},"V Anderson",{"name":295,"role":128},"Mark London, MD",{"lat":297,"lon":298},33.49182,-80.85565,{"facility":300,"status":7,"city":301,"state":302,"zip":303,"country":121,"contacts":304,"geoPoint":309},"Galen Medical Group","Chattanooga","Tennessee","37421",[305,307],{"name":306,"role":125},"K Norwood",{"name":308,"role":128},"S Phade, MD",{"lat":310,"lon":311},35.04563,-85.30968,{"facility":313,"status":314,"city":315,"state":302,"zip":316,"country":121,"geoPoint":317},"Fresenius Vascular Care Memphis MSO","TERMINATED","Memphis","38115",{"lat":318,"lon":319},35.14953,-90.04898,{"facility":321,"status":7,"city":322,"state":323,"zip":324,"country":121,"contacts":325,"geoPoint":330},"Baylor Scott & White Heart and Vascular Hospital","Dallas","Texas","75226",[326,328],{"name":327,"role":125},"R Shabbir",{"name":329,"role":128},"Stephen Hohmann, MD",{"lat":331,"lon":332},32.78306,-96.80667,{"facility":334,"status":7,"city":335,"state":323,"zip":336,"country":121,"contacts":337,"geoPoint":342},"Aqua Research Institute Llc","Houston","77058",[338,340],{"name":339,"role":125},"R Rachal",{"name":341,"role":128},"Rupal Patel, MD",{"lat":343,"lon":344},29.76328,-95.36327,{"facility":346,"status":7,"city":347,"state":348,"zip":349,"country":121,"contacts":350,"geoPoint":357},"HealthQare Associates","Arlington","Virginia","22201",[351,355],{"name":352,"role":125,"phone":353,"email":354},"M Lewandowski","703-908-0800","Magdalena.Lewandowski@AzuraCare.com",{"name":356,"role":128},"Homayoun Hashemi, MD, FACS, RVT, RPVI",{"lat":358,"lon":359},38.88101,-77.10428,{"facility":361,"status":7,"city":362,"state":348,"zip":363,"country":121,"contacts":364,"geoPoint":369},"Physicians Care of Virginia","Roanoke","24014",[365,367],{"name":366,"role":125},"A Johnson",{"name":368,"role":128},"Ryan Evans, MD",{"lat":370,"lon":371},37.27097,-79.94143,{"facility":373,"status":7,"city":374,"state":348,"zip":375,"country":121,"contacts":376,"geoPoint":381},"Sentara Health","Virginia Beach","23454",[377,379],{"name":378,"role":125},"S Havert",{"name":380,"role":128},"Samuel Steerman, MD",{"lat":382,"lon":383},36.85293,-75.97799,[385],{"name":386,"role":125,"phone":387,"email":388},"Katy Feeny","443-862-2024","kfeeny@sonavex.com",[],[],[],{"nct_id":4,"conditions":393,"biomarkers":396},[394,395],"Chronic Kidney Disease, Stage 5","Diabetes Mellitus",[],{"nct_id":4,"found":14,"summary":398,"prompt_version":407},{"design":399,"status":400,"heading":6,"summary":401,"follow_up":402,"word_count":403,"commitments":404,"compensation":405,"drugs_mentioned":406},"This is a randomized study with two groups, aiming to enroll 304 participants. One group will use the EchoMark\u002FEchoSure device, and the other will receive standard care.","completed","This study is looking at how well a new device, the EchoMark\u002FEchoSure System, helps doctors understand if an arteriovenous fistula (AVF) is maturing correctly. An AVF is a surgically created connection between an artery and a vein, often used for dialysis in people with End Stage Renal Disease or Diabetes. The study compares using this device every two weeks to standard care, which involves physical exams. Researchers want to see if the EchoMark\u002FEchoSure System can help reduce the time it takes for an AVF to be ready for use. You may be able to join if you are between 18 and 84 years old, are not pregnant or breastfeeding, and are able to attend all study visits. The study aims to measure the safety and effectiveness of the device over 6 months. The current recruitment status is unclear.","Participants will be followed for safety and effectiveness for 6 months after starting the study.",138,"If you are in the device group, you will have the EchoMark implanted during AVF creation and return every two weeks for an EchoSure scan until your fistula is ready. If you are in the standard care group, you will have physical exams at 2 and 4-6 weeks.","Not stated in the trial record.",[31],"v2"]