Clinical trials: Hemodialysis Catheter
Hemodialysis
Ex Vivo Microbiological Assessment of an Anti-biofilm Catheter in Acute Dialysis Application
The clinical study aims at providing data on antimicrobial efficiency and a supposed additional preventive effect on catheter-related infections of a catheter with antibacterial surface coating in comparison to standard catheters…
- Trial name
- ABBA (NCT00621114)
- Testing
- GamCath® central venous catheter, GamCath Dolphin® Protect central venous catheter
- Where
- Germany
- Volunteers
- 69 people
- Sponsor
- Vantive Health LLC
Catheter-Related Infections, Citrate Adverse Reaction
DuraLock-C Catheter Lock Solution
To evaluate the safety and performance of DuraLock-C 4.0%, 30.0%, and 46.7% for the maintenance of central venous catheter (CVC) patency in adult hemodialysis (HD) patients
- Trial name
- NCT04787926
- Testing
- Locking Solution
- Where
- France
- Volunteers
- 17 people
- Sponsor
- Medical Components, Inc dba MedComp
Dysfunctional Hemodialysis Catheters
A Study of Tenecteplase for Restoration of Function in Dysfunctional Hemodialysis Catheters
This was a Phase III, randomized, double-blind, placebo-controlled study conducted at 37 centers in the United States. 150 subjects ≥ 16 years of age who required hemodialysis (HD) and had a dysfunctional HD catheter were…
- Trial name
- TROPICS 3 (NCT00396032)
- Testing
- tenecteplase
- Volunteers
- 150 people
- Sponsor
- Genentech, Inc.
Chronic Kidney Diseases, Chronic Kidney Failure
SelfWrap-Assisted Arteriovenous Fistulas
This is a single-center, prospective, single-arm clinical study to evaluate the feasibility, safety, and performance of VenoStent's SelfWrap® Bioabsorbable Perivascular Wrap on arteriovenous fistulas (AVFs).
- Conditions
- Chronic Kidney Diseases, Chronic Kidney Failure, End Stage Renal Disease, End Stage Kidney Disease
- Trial name
- SW-AVF (NCT05418816)
- Testing
- SelfWrap Bioabsorbable Perivascular Wrap
- Where
- Paraguay
- Volunteers
- 20 people
- Sponsor
- VenoStent
Hemodialysis, Tunneled Catheter, Qatar
Management of Tunneled Catheter Thrombosis in Hemodialysis Patients: Prospective Study From Qatar
Goal of the study: A- To find out the best protocol for catheter lock solution to decrease the prevalence of catheter thrombosis 1. - The time to first episode of catheter thrombosis lead to catheter change. 2.
- Trial name
- NCT02868697
- Testing
- TauroLock U 25000, (TauroLock Hep500)
- Where
- Qatar
- Volunteers
- 170 people
- Sponsor
- Hamad Medical Corporation
Peripheral Arterial Disease
Rapamycin Coated Balloon Dilation Catheter for Arteriovenous Fistula
Verify the effectiveness and safety of rapamycin coated balloon dilation catheter for the treatment of dialysis pathway stenosis or blockage lesions.
- Trial name
- NCT06029569
- Testing
- Rapamycin drug balloon angioplasty, Paclitaxel drug balloon angioplasty
- Volunteers
- 256 people
- Sponsor
- Shanghai Bomaian Medical Technology Co., Ltd
Dysfunctional Hemodialysis Catheters
A Study of Tenecteplase for Restoration of Function in Dysfunctional Hemodialysis (HD) Catheters
This was a Phase III, open-label study conducted at 44 centers in the United States, Canada, and Puerto Rico. 223 subjects who required hemodialysis (HD) and had a dysfunctional HD catheter were enrolled in the study.
- Trial name
- TROPICS 4 (NCT00396253)
- Testing
- Tenecteplase
- Volunteers
- 223 people
- Sponsor
- Genentech, Inc.
Kidney Failure, Chronic, Catheter-Related Infections
Study Assessing Safety & Effectiveness of a Catheter Lock Solution in Dialysis Patients to Prevent Bloodstream Infection
The purpose of this study is determine safety and effectiveness of Neutrolin, a catheter lock solution, for prevention of central venous catheter associated bloodstream infection in hemodialysis patients.
- Trial name
- NCT02651428
- Testing
- Neutrolin, Heparin
- Where
- 5 sites in United States
- Volunteers
- 806 people
- Sponsor
- CorMedix Therapeutics
Bacteremia, Gram-Positive Bacterial Infections
Linezolid in the Treatment of Hemodialysis Patients With Catheter-Related Gram-Positive Bloodstream Infections
This study will treat hemodialysis patients who have a central catheter that is thought to be infected with a specific bacteria (Gram positive bacteria).
- Trial name
- NCT00108433
- Testing
- Cefazolin IV, Linezolid IV, Vancomycin (IV)
- Where
- 17 sites in United States, Colombia and 5 more
- Volunteers
- 61 people
- Sponsor
- Pfizer
End Stage Renal Disease (ESRD)
HeRO Graft Compared to Permanent Catheters for End Stage Renal Disease (ESRD) Patients Receiving Hemodialysis
The main objective of this research study was to compare the following outcomes between patients with a Hemodialysis Reliable Outflow (HeRO) Graft and patients with a cuffed catheter for dialysis access over one year: quality of…
- Trial name
- NCT01343251
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Merit Medical Systems, Inc.
Catheter-Related Infections
Open-Label Study to Assess Safety and Time to Catheter-related Bloodstream Infections (CRBSI) in Subjects From Birth to < 18 Years of Age
This study is a post-marketing approval requirement to assess the safety and time to Catheter-related Bloodstream Infections (CRBSI) of DefenCath in pediatric population (birth to less than 18 years of age) who are on chronic HD…
- Trial name
- NCT06714864
- Testing
- (taurolidine and heparin) catheter lock solution, Standard of Care
- Where
- 6 sites in United States
- Volunteers
- 36 people
- Sponsor
- CorMedix Therapeutics
End Stage Renal Disease (ESRD)
To Compare the Efficacy and Safety of the ATEV With AVF in Female Patients With End-Stage Renal Disease Requiring Hemodialysis
The goal of this clinical trial is to compare the number of catheter-free days (CFD) and the rate and severity of any dialysis access-related infections between the ATEV and AVF groups over 12 months in patients with end-stage…
- Trial name
- NCT05908084
- Testing
- Acellular Tissue Engineered Vessel (ATEV), AVF
- Where
- 32 sites in United States
- Volunteers
- 121 people
- Sponsor
- Humacyte, Inc.
Hemodialysis
HeRO Vascular Access Device Bacteremia Study
The purpose of this study is to compare the safety and effectiveness of the HeRO Vascular Access Device in access challenged (e.g., catheter-dependent) hemodialysis patients.
- Trial name
- NCT00889564
- Testing
- HeRO Vascular Access Device
- Where
- 7 sites in United States
- Volunteers
- 38 people
- Sponsor
- Merit Medical Systems, Inc.
Needle Phobia, Phobic Disorders
Effect of Including Synera® in Discussions on Dialysis Access Conversion in Patients With Needle Phobias
An arteriovenous fistula or graft access (AVF/AVG) for dialysis is often considered a superior option for delivery of dialysis, but requires needles to be inserted.
- Trial name
- NCT01623583
- Testing
- Enhanced Needle Phobia Intervention, Standard Needle Phobia Intervention
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- Davita Clinical Research
Dialysis Catheter Infections
Efficacy Study to Evaluate B-Lock™ as an Antimicrobial Lock Solution in Dialysis Patients With a CVC
Hypothesis: B-Lock is a safe and effective catheter lock solution that will maintain catheter patency and reduce Central Line Associated Blood Stream Infections (CLABSI) in dialysis patients using a central venous catheter (CVC)…
- Trial name
- NCT01989091
- Testing
- B-Lock, Heparin 5,000 U/mL
- Where
- 21 sites in Hungary, Poland
- Volunteers
- 270 people
- Sponsor
- Great Lakes Pharmaceuticals Inc.
Arteriovenous Fistula Stenosis
Peripheral Scoring Drug-coated Balloon in the Treatment of Hemodialysis Arteriovenous Fistula Stenosis
This is a prospective, multi-center, single-arm target value clinical study to study the safety and effectiveness of Peripheral Scoring Drug-coated Balloon dilatation catheters in the treatment of hemodialysis arteriovenous…
- Trial name
- SCDB (NCT06422845)
- Testing
- Dissolve AV Peripheral Scoring Drug-coated Balloon
- Where
- 33 sites in China
- Volunteers
- 328 people
- Sponsor
- DK Medical Technology (Suzhou) Co., Ltd.
End-Stage Renal Disease
Cook Enforcer Post-Market Study
The purpose of this study is to evaluate the performance of the Cook Advance® Enforcer™ 35 Focal-Force PTA Balloon Catheter (or Enforcer balloon) in treating narrowed blood vessels compared to treatment with a conventional…
- Trial name
- NCT03552289
- Testing
- Cook Advance® Enforcer 35 Focal-Force Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter, Conventional angioplasty balloon catheters
- Where
- 5 sites in United States
- Volunteers
- 211 people
- Sponsor
- Cook Research Incorporated
CKD, ESRD
Long Term Hemodialysis Catheters (LTHD) Post Market Clinical Follow up (PMCF)
The primary objective of this observational PMCF study is to collect clinical data on the safety and efficacy of Medcomp Long Term Hemodialysis (LTHD) Catheter Kits in compliance with MDR 2017/745.
- Trial name
- LTHD PMCF (NCT04782297)
- Testing
- Long term hemodialysis catheter
- Where
- 2 sites in United States, Spain
- Sponsor
- Medical Components, Inc dba MedComp
Peripheral Arterial Disease, Fistula
A Study of Hemodialysis Arteriovenous Fistulae Stenosis Treated With APERTO
To evaluate the safety and efficacy of Paclitaxel Eluting Hemodialysis Shunt Balloon Dilatation Catheter (APERTO) compared with the Balloon Dilatation catheter (OHICHO II) for the treatment of Arteriovenous Fistulae Stenosis in…
- Trial name
- NCT02962141
- Testing
- Paclitaxel Releasing Peripheral Balloon Dilatation Catheter, Balloon Dilatation Catheter
- Where
- 9 sites in China
- Volunteers
- 161 people
- Sponsor
- ZhuHai Cardionovum Medical Device Co., Ltd.
End Stage Renal Disease
Analysis of CRBSI Rates in Patients With a NexSite™ HD (Hemodialysis) Catheter
A U.S. multi-centre post approval registry to analyse the CRBSI rate in patients with the NexSite HD Catheter for long term vascular access for hemodialysis.
- Trial name
- NCT02453646
- Testing
- NexSite HD Patients
- Where
- 6 sites in United States
- Volunteers
- 120 people
- Sponsor
- Marvao Medical