[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640370":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":18,"centralContacts":19,"locations":18,"responsibleParty":25,"collaborators":18,"id":27,"slug":28,"hasResults":29,"nctId":30,"briefTitle":31,"officialTitle":31,"acronym":32,"eligibilityCriteria":33,"healthyVolunteers":29,"sex":34,"minAge":35,"maxAge":18,"enrollmentInfo":36,"targetDuration":18,"studyType":39,"phases":40,"briefSummary":42,"conditions":43,"keywords":18,"overallStatus":45,"whyStopped":18,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":18},{"fullName":5,"class":6},"Evolve Medicus, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"OnePoint Dialysis Cannula","EXPERIMENTAL","Single-site vascular access device intended to be used in patients receiving hemodialysis",[13],"Device: OnePoint Dialysis Cannula",[15],{"type":16,"name":9,"description":11,"armGroupLabels":17,"otherNames":18},"DEVICE",[9],null,[20],{"name":21,"role":22,"phone":23,"phoneExt":18,"email":24},"Britnee Ochabski","CONTACT","19493224050","OchabskiConsulting@gmail.com",{"type":26,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","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":37,"type":38},20,"ESTIMATED","INTERVENTIONAL",[41],"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.",[44],"Vascular Access","NOT_YET_RECRUITING","2026-05-13",{"date":48,"type":49},"2026-05-20","ACTUAL",{"date":51,"type":38},"2026-08-01",{"date":53,"type":38},"2027-08",{"name":5,"class":6}]