[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563238":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":31,"responsibleParty":95,"collaborators":20,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":20,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":20,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"Diality Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Professional Care and At Home","EXPERIMENTAL","Participants will receive dialysis therapy using the Moda-Flx Hemodialysis System™ in a Professional Care setting and At Home setting",[13],"Device: Moda-flx Hemodialysis System™",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Moda-flx Hemodialysis System™","The Moda-flx Hemodialysis System™ is a portable hemodialysis system",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Cynthia Silva, MD","STUDY_DIRECTOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Michael Gastauer","CONTACT","949-916-5851","HomeTrial@Diality.com",[32,51,66,81],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"North America Research Institute","RECRUITING","San Dimas","California","91773","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-117.80673,34.10668,{"lat":44,"lon":43},[47],{"name":48,"role":28,"phone":49,"phoneExt":20,"email":50},"Molly Way","(800) 797-1695","mpruitt@nariresearch.com",{"facility":52,"status":34,"city":53,"state":54,"zip":55,"country":38,"countryCode":39,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"Nephrology Associates of Knoxville","Knoxville","Tennessee","37920",{"type":41,"coordinates":57},[58,59],-83.92074,35.96064,{"lat":59,"lon":58},[62],{"name":63,"role":28,"phone":64,"phoneExt":20,"email":65},"Benjamin Brooks","865-323-3382","benjamin.brooks@dciinc.org",{"facility":67,"status":34,"city":68,"state":69,"zip":70,"country":38,"countryCode":39,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"aQua Research Institute, LLC","Houston","Texas","77058",{"type":41,"coordinates":72},[73,74],-95.36327,29.76328,{"lat":74,"lon":73},[77],{"name":78,"role":28,"phone":79,"phoneExt":20,"email":80},"Rhea Sharma","281-939-6516","rheas@aqua-ri.com",{"facility":82,"status":34,"city":83,"state":84,"zip":85,"country":38,"countryCode":39,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"University of Washington","Seattle","Washington","98104",{"type":41,"coordinates":87},[88,89],-122.33207,47.60621,{"lat":89,"lon":88},[92],{"name":93,"role":28,"phone":20,"phoneExt":20,"email":94},"Lori Linke","linkel@uw.edu",{"type":96,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100563238","moda-flx-hemodialysis-system-under-professional-care-settings-by-trained-individuals-and-at-home-by-participants-100563238",false,"NCT06613568","Moda-flx Hemodialysis System™ Under Professional Care Settings by Trained Individuals and At Home by Participants","Prospective, Non-Randomized, Multicenter, Open-Label Study Evaluating the Use of the Moda-flx Hemodialysis System™ Under Professional Care and At Home by Participants With End Stage Kidney Disease (ESKD) Who Are on Stable Dialysis Regimens","Inclusion Criteria:\n\n* Are between 18 and 80 years of age and Care Partner is at least 18 years of age at the time of signing consent.\n* Have a diagnosis of end stage kidney disease (ESKD) adequately treated by maintenance dialysis (defined as achieving a spKt\u002FV ≥ 1.2 OR stdKt\u002FV ≥ 2.1) and be deemed stable by their treating nephrologist prior to the end of the Screening Period\n* Have a well-functioning and stable vascular access (tunneled central venous catheter arteriovenous fistula, or graft) that allows a blood flow of at least 300 ml\u002Fmin prior to the end of Screening\n* Can successfully complete a Skills and Comprehension Assessment with a Care Partner prior to the completion of the Training Period.\n\nExclusion Criteria:\n\n* Hgb level of \\\u003C 9 g\u002FdL at Screening\n* Symptomatic intradialytic hypotension requiring medical intervention (ultrafiltration turned off, bolus of fluid) in at least two treatments during the Run-In period defined as:\n\n  1. Persistent pre-dialysis sitting SBP \\\u003C 100 mmHg despite medical therapy,\n  2. Nadir intradialytic Systolic Blood Pressure (SBP) \\\u003C 90 mmHg, if Subject's pre-HD SBP \\\u003C 160 mmHg\n  3. Nadir intradialytic SBP \\\u003C 100 mmHg if Subject's pre-HD SBP ≥ 160 mmHg\n* Documented history of non-adherence to dialysis therapy that would prevent successful completion of the study\n* Participant had an average ultrafiltration rate \\> 13 mL\u002Fkg\u002Fhour during the last 2 weeks prior to Screening, per medical records.\n* Had a significant cardiovascular adverse event within the last 90 days prior to Screening.","ALL","18 Years","80 Years",{"count":108,"type":109},50,"ESTIMATED","INTERVENTIONAL",[112],"NA","The purpose of this study is to evaluate the safety and efficacy of the Moda-flx Hemodialysis System™ when used Under Professional Care Settings by trained individuals and At Home by trained Participants and Care Partners",[115],"End Stage Kidney Disease",[117,118,119,120,121,122,123,124],"Renal Disease","Hemodialysis Complication","Kidney Diseases","Dialysis","Renal Dialysis","Hemodialysis, Home","Renal Insufficiency","Kidney Failure, Chronic","2025-11-05",{"date":127,"type":128},"2025-11-10","ACTUAL",{"date":130,"type":128},"2025-10-06",{"date":132,"type":109},"2027-09",{"name":5,"class":6},4]