[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641241":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":42,"collaborators":20,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":20,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":20,"enrollmentInfo":55,"targetDuration":20,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":20,"overallStatus":71,"whyStopped":20,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Medical University of Vienna","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Insertion of a tunneled hemodialysis catheter with Endexo® technology for haemodialysis treatment","ACTIVE_COMPARATOR","Study participants will be recruited among those patients with the need of insertion of a tunneled catheter to perform hemodialysis who attend the recruitment site (Medical University of Vienna, Department of Internal Medicine III, Division of Nephrology and Dialysis) for routine care. A tunneled hemodialysis catheter BioFlo Duramax with Endexo® technology (Merit Medical, Utah, USA) will be implanted. As a standard catheter lock solution 4% citrate (applied in each of the 2 lumens after each dialysis session) will be used. Care of the tunneled catheter in the study sites will be followed established standards including dressing changes, exit site care and hygiene. After each hemodialysis session the exit site will be inspected and covered with 2.0% chlorhexidine dressing (Tegaderm CHG, 3M, Neuss, Germany). Chronic haemodialyisis treatment will be held in a regular setting based on the patient's dialysis requirements.",[13],"Device: Insertion of a tunneled hemodialysis catheter BioFlo Duramax with Endexo® technology (Merit Medical, Utah, USA)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Insertion of a tunneled hemodialysis catheter BioFlo Duramax with Endexo® technology (Merit Medical, Utah, USA)","In this pilot study the tunneled hemodialysis catheter BioFlo Duramax with Endexo® technology (Merit Medical, Utah, USA) will be compared with historical catheter dysfunction rates in standard tunneled dialysis catheters (silicone or polyurethane) in chronic dialysis population.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Gürkan Sengölge, Assoc. Prof","CONTACT","+43 1 40400 43890","guerkan.sengoelge@meduniwien.ac.at",[28],{"facility":5,"status":20,"city":29,"state":20,"zip":20,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"Vienna","Austria","AT",{"type":33,"coordinates":34},"Point",[35,36],16.37208,48.20849,{"lat":36,"lon":35},[39],{"name":40,"role":24,"phone":41,"phoneExt":20,"email":26},"Gürkan Sengölge, Assoc. Prof.","+43 1 40400-43890",{"type":43,"investigatorFullName":44,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Guerkan SENGOELGE","Assoc. Prof. Priv.-Doz. Dr. med.univ.","100641241","impact-of-a-tunneled-hemodialysis-catheter-with-endexo-technology-on-catheter-dysfunction-compared-with-historical-catheter-dysfunction-data-in-standard-catheters-100641241",false,"NCT07655544","Impact of a Tunneled Hemodialysis Catheter With Endexo® Technology on Catheter Dysfunction Compared With Historical Catheter Dysfunction Data in Standard Catheters","Impact of a Tunneled Hemodialysis Catheter With Endexo® Technology on Catheter Dysfunction Compared With Historical Catheter Dysfunction Data in Standard Catheters (Silicone or Polyurethane): A Pilot Study","Inclusion Criteria:\n\n* Adult patients aged greater than 18 years\n* Written informed consent\n* Requirement for hemodialysis using a tunneled dialysis catheter\n\nExclusion Criteria:\n\n* Children aged less than 18 years\n* Uncontrolled infection; defined as positive blood culture in the past seven days before catheter insertion and\u002F or elevated C-reactive protein \\[CRP \\>5 mg\u002Fdl (normal \\\u003C0.5 mg\u002Fdl)\\] at screening","ALL","18 Years",{"count":56,"type":57},50,"ESTIMATED","INTERVENTIONAL",[60],"NA","There is evidence that central venous catheters made of the permanent and non-eluting integral polymer Endexo® are more resistant to intraluminal thrombosis. This has a direct reducing effect on catheter malfunctions. Indirectly, due to reduced handling of the dysfunctional catheter, this may lead to a diminished rate of catheter related infections. Since catheter malfunctions and infections represent leading complications in a dialysis population, dialysis catheters produced with Endexo® technology have the potential to have beneficial clinical effects. In addition to improving patient outcomes, this could also reduce overall costs. In this pilot study the tunneled hemodialysis catheter BioFlo Duramax with Endexo® technology (Merit Medical, Utah, USA) will be compared with historical catheter dysfunction rates in standard tunneled dialysis catheters (silicone or polyurethane) in chronic dialysis population.",[63,64,65,66,67,68,69,70],"Haemodialysis","Haemodialysis Complication","Vascular Access","Vascular Access Complication","ESRD (End Stage Renal Disease)","Dialysis Access Dysfunction","Dialysis Catheter","Dialysis Catheter Infections","NOT_YET_RECRUITING","2026-06-11",{"date":74,"type":75},"2026-06-18","ACTUAL",{"date":77,"type":57},"2026-08-01",{"date":79,"type":57},"2027-12-31",{"name":5,"class":6},1]