[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100476920":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":176,"collaborators":20,"id":178,"slug":179,"hasResults":180,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":180,"sex":186,"minAge":187,"maxAge":20,"enrollmentInfo":188,"targetDuration":20,"studyType":191,"phases":192,"briefSummary":194,"conditions":195,"keywords":20,"overallStatus":38,"whyStopped":20,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":207},{"fullName":5,"class":6},"Voyager Biomedical","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Ark Implantation","EXPERIMENTAL","Single arm study. Depending on the clinical needs of the patient, the physician will decide if a single return device is needed (ex. easily cannulatable arterial pull site but the venous return access site is poorly accessible for cannulation) or two devices (both arterial pull and venous return are poorly accessible for cannulation).",[13],"Device: VenaSure",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","VenaSure","The device will be surgically implanted at the access site in subjects undergoing routine hemodialysis. The device is expected to provide a target to aid in long-term cannulation success.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Stephen Hohmann, MD","Baylor Scott and White Health","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Britnee Ochabski","CONTACT","9493224050","bochabski@voyagerbiomedical.com",{"name":33,"role":29,"phone":20,"phoneExt":20,"email":34},"Supraj Amunje","samunje@voyagerbiomedical.com",[36,57,74,91,109,126,144,159],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Trinity Research Group","RECRUITING","Dothan","Alabama","36301","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-85.39049,31.22323,{"lat":48,"lon":47},[51,55],{"name":52,"role":29,"phone":53,"phoneExt":20,"email":54},"Emily Ivey Director","334-456-5511","eivey.trinity@gmail.com",{"name":56,"role":25,"phone":20,"phoneExt":20,"email":20},"Jason Beaver, MD",{"facility":58,"status":38,"city":59,"state":60,"zip":61,"country":42,"countryCode":43,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Apex Research","Riverside","California","92505",{"type":45,"coordinates":63},[64,65],-117.39616,33.95335,{"lat":65,"lon":64},[68,72],{"name":69,"role":29,"phone":70,"phoneExt":20,"email":71},"Karina Trejo","951-529-4708","ktrejo@nephrologyamg.com",{"name":73,"role":25,"phone":20,"phoneExt":20,"email":20},"Dalia Dawoud, MD",{"facility":75,"status":38,"city":76,"state":77,"zip":78,"country":42,"countryCode":43,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Brigham and Women's Hospital","Boston","Massachusetts","02115",{"type":45,"coordinates":80},[81,82],-71.05977,42.35843,{"lat":82,"lon":81},[85,89],{"name":86,"role":29,"phone":87,"phoneExt":20,"email":88},"Danielle Montano CRC","617-525-8555","dmontano2@bwh.harvard.edu",{"name":90,"role":25,"phone":20,"phoneExt":20,"email":20},"Mohamed Hussain, MD",{"facility":92,"status":38,"city":93,"state":94,"zip":95,"country":42,"countryCode":43,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Northwell Health","Hyde Park","New York","11042",{"type":45,"coordinates":97},[98,99],-73.93319,41.78482,{"lat":99,"lon":98},[102,106],{"name":103,"role":29,"phone":104,"phoneExt":20,"email":105},"Yana Etkin, MD","(516) 233-3701","yetkin@northwell.edu",{"name":107,"role":29,"phone":104,"phoneExt":20,"email":108},"Victoria Wairimu","mwairimu@northwell.edu",{"facility":110,"status":38,"city":111,"state":112,"zip":113,"country":42,"countryCode":43,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"MUSC Health Orangeburg","Orangeburg","South Carolina","29118",{"type":45,"coordinates":115},[116,117],-80.85565,33.49182,{"lat":117,"lon":116},[120,124],{"name":121,"role":29,"phone":122,"phoneExt":20,"email":123},"Kristen Covington","(803) 395-2021","covingkr@musc.edu",{"name":125,"role":25,"phone":20,"phoneExt":20,"email":20},"Mark London, MD",{"facility":127,"status":38,"city":128,"state":129,"zip":130,"country":42,"countryCode":43,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Cardiothoracic and Vascular Surgeons","Austin","Texas","78756",{"type":45,"coordinates":132},[133,134],-97.74306,30.26715,{"lat":134,"lon":133},[137,142],{"name":138,"role":29,"phone":139,"phoneExt":140,"email":141},"Shir Yelovitch, PhD","512-459-8753","214","SYelovitch@ctvstexas.com",{"name":143,"role":25,"phone":20,"phoneExt":20,"email":20},"Adam Turley, MD",{"facility":145,"status":38,"city":146,"state":129,"zip":147,"country":42,"countryCode":43,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"Baylor Scott & White","Dallas","75246",{"type":45,"coordinates":149},[150,151],-96.80667,32.78306,{"lat":151,"lon":150},[154,158],{"name":155,"role":29,"phone":156,"phoneExt":20,"email":157},"Rehma Shabbir","214-820-1722","Rehma.Shabbir@BSWHealth.org",{"name":23,"role":25,"phone":20,"phoneExt":20,"email":20},{"facility":160,"status":38,"city":161,"state":162,"zip":163,"country":42,"countryCode":43,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"Fairlawn Surgery Center","Roanoke","Virginia","24014",{"type":45,"coordinates":165},[166,167],-79.94143,37.27097,{"lat":167,"lon":166},[170,174],{"name":171,"role":29,"phone":172,"phoneExt":20,"email":173},"Aleisha Umber Director","540-904-6170","AUMBER@FSCMED.COM",{"name":175,"role":25,"phone":20,"phoneExt":20,"email":20},"Ryan Evans, MD",{"type":177,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100476920","access-cannulation-trial-ii-100476920",false,"NCT05490225","Access Cannulation Trial II","A Study to Evaluate the Safety and Effectiveness of Voyager's Access Device for Patients Undergoing Routine Hemodialysis (Access Cannulation Trial II)","ACT II","Inclusion:\n\n1. The subject's AVF is deemed uncannulatable because:\n\n   1. The subject's anticipated cannulation zone(s) is\u002Fare \\>6mm in depth from the surface of the skin to the anterior wall of the access vein as confirmed by ultrasound within 8 weeks prior to device implantation (each zone, Arterial\u002FPull and Venous\u002FPush, shall be assessed independently of one another for device placement):\n\n      * Arterial\u002FPull Zone: \\_\\_\\_\\_\\_ mm deep\n      * Venous\u002FPush Zone: \\_\\_\\_\\_\\_ mm deep\n\n      OR\n   2. The subject's dialysis unit (which includes an experienced cannulator) attests that repeated cannulation is not achievable in their clinic due to one of the following:\n\n      * Failed access attempt in a fistula that was previously approved for cannulation, or\n      * Unable to palpate the fistula such that cannulation is not possible without patient risk.\n2. The access surgeon caring for the subject attests that the device is likely to be at least equivalent to other methods (such as venous transposition or suction-assisted lipectomy) that could make the AVF easier to access and reduce risk of cannulation infiltrations.\n3. The subject has either a radio-cephalic, brachio-cephalic or transposed brachio-basilic fistula.\n\nExclusion:\n\n1. The subject's access vein is \\>15mm in depth at either cannulation zones as measured by ultrasound within 8 weeks prior to device implantation.\n\n   * Arterial\u002FPull Zone: \\_\\_\\_\\_\\_ mm in depth\n   * Venous\u002FPush Zone: \\_\\_\\_\\_\\_ mm in depth Note: these values should match inclusion criteria #1\n2. Both bidimensional measurements in the subject's access vein have a diameter of \\\u003C4mm, taken with a tourniquet in place or through manual compression to the outflow, as measured by ultrasound within 8 weeks prior to device implantation (cannulation zone specific - one zone does not affect the other's eligibility).\n\n   * Arterial\u002FPull Zone: \\_\\_\\_\\_\\_ x \\_\\_\\_\\_\\_ mm in diameter\n   * Venous\u002FPush Zone: \\_\\_\\_\\_\\_ x \\_\\_\\_\\_\\_ mm in diameter\n3. The subject has a flow rate of \\\u003C550mL\u002Fmin in the inflow artery proximal to the arterial anastomosis as measured by ultrasound within 8 weeks prior to device implantation.\n\n   • Flow: \\_\\_\\_\\_\\_ mL\u002Fmin\n4. The subject does NOT have a prescription to receive maintenance hemodialysis at least 2 times per week.\n5. The subject's life expectancy is \\\u003C1 year per the Investigator.\n6. The subject does NOT have a signed and dated consent form.\n7. The AVF is a non-transposed basilic or brachial vein outflow AVF.\n8. The subject has high flow rates placing them at risk for heart failure and death at the discretion of the Investigator.\n9. The subject has a known skin infection, hypersensitive skin, skin breakdown\u002Ferosion or skin allergies at the potential implant sites.\n10. The subject has a known active systemic infection or positive blood cultures present.\n11. The subject's AVF has undergone a major revision and at the discretion of the Investigator can impact fistula viability and device placement (such as DRIL or PTFE segment insertion, banding, aneurysm repair, etc.), or the subject has had an occurrence of and\u002For intervention for AV access stenosis or thrombosis within the past month (excluded to avoid unnecessary placement into an AVF with a high likelihood of failure).\n12. The subject is \\\u003C18 years of age.\n13. The subject plans to become pregnant prior to their potential treatment date.\n14. The subject has a body mass index \\>50kg\u002Fm2.\n15. The subject has a known clinically significant bleeding or coagulation disorder, including but not limited to low platelet count (\\\u003C50,000), hypercoagulable state (e.g., antithrombin IE deficiency, antiphospholipid or anticardiolipin antibodies, Factor V Leiden, circulating Lupus anticoagulant, current, heparin-induced thrombocytopenia, protein C or S deficiency, history of recurrent deep vein thrombosis not related to AV access).\n16. The subject has an active malignancy.\n17. The subject has a known or suspected allergy to titanium, aluminum, or vanadium.\n18. The subject has had a significant cardiovascular event\u002Fintervention that makes them a poor surgical candidate such as myocardial infarction, angioplasty, or stent placement within 3 months of implantation.\n19. The subject has had a significant peripheral vascular disease requiring a major intervention within the previous 12 months (in the target limb).\n20. The subject has had a significant neurovascular event such as stroke or major intervention within the previous 12 months.\n21. The subject has an uncontrolled major symptomatic medical problem per the Investigator.\n22. The subject has a likelihood of poor protocol compliance due to mental incapacity, an inability to understand treatment instructions, or for any other reason in the opinion of the Investigator.\n23. The subject is currently participating in another investigational drug or device investigation that could clinically interfere with the endpoints of this investigation.\n24. The subject's conversion to home hemodialysis is anticipated at any point during their foreseeable participation in this investigation.","ALL","18 Years",{"count":189,"type":190},100,"ESTIMATED","INTERVENTIONAL",[193],"NA","This is a pivotal, interventional, prospective, single-arm, open-label, multi-site clinical investigation intended to support FDA clearance of the study device based on the safety and efficacy of the device in cannulating arteriovenous fistulas (AVFs) for hemodialysis procedures.",[196,197],"Dialysis; Complications","Vascular Access Complication","2025-10-27",{"date":200,"type":201},"2025-10-29","ACTUAL",{"date":203,"type":201},"2025-04-23",{"date":205,"type":190},"2027-03-25",{"name":5,"class":6},8]