[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Evolve Medicus, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":39},{"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":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"100640370","early-feasibility-study-to-assess-the-safety-and-effectiveness-of-the-onepoint-dialysis-cannulatm-as-a-single-site-vascular-access-device-for-hemodialysis-procedures-100640370",false,"NCT07599085","Early Feasibility Study to Assess the Safety and Effectiveness of the OnePoint Dialysis CannulaTM as a Single-Site Vascular Access Device for Hemodialysis Procedures","ONEPOINT-01","Inclusion Criteria:\n\n1. Subject is an adult patient ≥ 18 years of age.\n2. Subject with the ability to attend \"in-center\" hemodialysis.\n3. Subject has a requirement of hemodialysis 3 times\u002Fweek.\n4. Subject has an AVF that was determined to be mature by standard clinical definition\n5. Subject with ≥ 3 months stable in center hemodialysis with \\>90 days use of an AV fistula cannulated with 2 needles with no evidence of stenosis or thrombosis.\n6. Subject has an AVF that meets all of the following Rule of 5s:\n\n   * Flow ≥ 500 mL\u002Fmin\n   * Diameter ≥ 5 mm\n   * Depth ≤ 5 mm from the skin surface\n   * Length ≥ 5 cm usable for cannulation\n7. Subject does not have any established lesions or stents in the access circuit as confirmed by ultrasound.\n8. Subject dialyzes at a center that can confirm 30-day data collection on cannulations and is willing to cooperate in performing real-time assessments and record keeping per Sponsor requirements, to assure subject safety requirements.\n\nExclusion Criteria:\n\n1. Subject has an existing arteriovenous graft.\n2. Subject has any active infection within the past 90 days.\n3. Subject is currently receiving or planning home hemodialysis.\n4. Subject has a distorted anatomy and\u002For local vascular injury.\n5. Subject has a change in blood thinner regimen in the last 60 days.\n6. Subject has any unstable medical or psychiatric conditions likely to impair their ability to participate in the study.\n7. Subject has a known history of clinically significant IV drug use.\n8. Subject is a pregnant or nursing woman, or anticipates pregnancy in the next 3 months.\n9. Subject is enrolled in another study that could confound the results of this study, without documented pre-approval.\n10. Subject has a known allergy to plastics.\n11. Subject is unwilling to sign the study's consent form.\n12. Subject has a life expectancy of less than 12 months.","ALL","18 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"NA","This is an early feasibility, pre-market, prospective, interventional, single-arm, non-randomized \u002F open-label study intended to support a future pivotal IDE study for eventual FDA clearance of the study device based on the safety and efficacy of the device in cannulating arteriovenous fistulas (AVFs) for hemodialysis procedures.",[26],"Vascular Access","NOT_YET_RECRUITING","2026-05-13",{"date":30,"type":31},"2026-05-20","ACTUAL",{"date":33,"type":20},"2026-08-01",{"date":35,"type":20},"2027-08",{"name":37,"class":38},"Evolve Medicus, Inc.","INDUSTRY",""]