Clinical trials: Hemodialysis Access
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
End Stage Renal Disease (ESRD), Kidney Failure
A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease
The goal of the CSP-2002 clinical trial is to evaluate the safety and effectiveness of the InnAVasc Arteriovenous Graft (IG) for hemodialysis (HD) access in patients with end-stage renal disease (ESRD).
- Conditions
- End Stage Renal Disease (ESRD), Kidney Failure, Chronic Renal Disease, Hemodialysis
- Trial name
- NCT04671771
- Testing
- InnAVasc Arteriovenous Graft (IG) surgical implant
- Where
- 22 sites in United States
- Volunteers
- 133 people
- Sponsor
- W.L.Gore & Associates
Arteriovenous Fistula Stenosis, Arteriovenous Fistula
A Prospective, Multi-center Study to Evaluate Efficacy and Safety of BSJ020R in Treatment of AVF for Hemodialysis (RANGER AV Japan Study)
A prospective, multi-center study to evaluate efficacy and safety of BSJ020R in treatment of AVF for hemodialysis
- Conditions
- Arteriovenous Fistula Stenosis, Arteriovenous Fistula, Vascular Access
- Trial name
- NCT06639451
- Testing
- RANGER™ Paclitaxel Coated Balloon Catheter
- Where
- 8 sites in Japan
- Volunteers
- 186 people
- Sponsor
- Boston Scientific Corporation
Arteriovenous Fistula
An Efficacy and Safety Study of SRM003 in the Treatment of Subjects Undergoing Creation of an Arteriovenous Fistula to Facilitate Hemodialysis Access
A study to evaluate the efficacy of SRM003 treatment versus participating sites' standard practice treatment in improving the rate of AVF maturation and use in subjects with end-stage renal disease undergoing surgery for creation…
- Trial name
- NCT01806545
- Testing
- SRM003, Participating Site's standard practice
- Where
- 47 sites in United States
- Volunteers
- 64 people
- Sponsor
- Shire
Chronic Kidney Diseases, End Stage Renal Disease
SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study
This is a prospective, randomized, multi-center clinical trial for chronic kidney disease (CKD) patients referred for creation of a new arteriovenous fistula (AVF) in order to assess the safety and effectiveness of SelfWrap, a…
- Conditions
- Chronic Kidney Diseases, End Stage Renal Disease, Arteriovenous Fistula, Hemodialysis Access Failure
- Trial name
- SAVE-FistulaS (NCT06001827)
- Testing
- SelfWrap Bioabsorbable Perivascular Wrap, Untreated AVF Control
- Where
- 28 sites in United States
- Volunteers
- 600 people
- Sponsor
- VenoStent
End-Stage Renal Disease
Decellularized Femoral Artery Allograft (Nexeon AVX) Prospective Registry
Post market registry to assess the safety and efficacy of a novel decellularized human femoral artery allograft (Nexeon AVX Decellularized Femoral Artery,
- Trial name
- NCT05880537
- Testing
- Nexeon Arterial Venous Allograft
- Where
- 4 sites in United States
- Volunteers
- 100 people
- Sponsor
- LifeNet Health
Renal Failure, End Stage Renal Disease
Safety and Efficacy Assessment of HAV in Patients Needing Vascular Access for Dialysis
This is a Phase 2, prospective, multicenter, open-label, single-arm study of the Human Acellular Vessel (HAV).
- Conditions
- Renal Failure, End Stage Renal Disease, Vascular Access, Hemodialysis
- Trial name
- NCT04135417
- Testing
- HAV
- Where
- 2 sites in Poland
- Volunteers
- 30 people
- Sponsor
- Humacyte, Inc.
Renal Disease, Kidney Failure
The Boston Scientific ACCESS Trial
The Boston Scientific ACCESS trial seeks to study the safety and to evaluate the success of the Fusion™ Vascular Access Graft for patients in need of early vascular access for hemodialysis.
- Trial name
- ACCESS (NCT00260728)
- Testing
- vascular access graft implantation
- Where
- 8 sites in United States
- Volunteers
- 149 people
- Sponsor
- Maquet Cardiovascular
Chronic Kidney Disease
A Study of PRT-201 Administered After Arteriovenous Graft (AVG) Creation in Patients With Chronic Kidney Disease
PRT-201 is a recombinant human type-I pancreatic elastase intended for local, long-lasting dilation of the AVG venous anastomosis and outflow vein.
- Trial name
- PRT-201-102 (NCT01001351)
- Testing
- PRT-201
- Where
- 16 sites in United States
- Volunteers
- 89 people
- Sponsor
- Proteon Therapeutics
End Stage Renal Disease, End Stage Renal Failure on Dialysis
First-in-Human (FIH) Study of the Xeltis Hemodialysis Access Graft
A feasibility study is to assess the preliminary safety and performance of the Xeltis hemodialysis access (aXess) graft.
- Trial name
- aXess-FIH (NCT04898153)
- Testing
- aXess
- Where
- 6 sites in Belgium, Italy and 2 more
- Volunteers
- 20 people
- Sponsor
- Xeltis
Hemodialysis
Ultrasound Instrument to Prevent Dialysis Graft Failure
This research study aims to show that a newly developed investigational Doppler instrument can reliably measure blood flow in dialysis access grafts, to see if a decrease in the flow may be a sign of impending graft failure and…
- Trial name
- NCT00309348
- Testing
- Weekly measurement of graft flow
- Where
- 2 sites in United States
- Volunteers
- 111 people
- Sponsor
- DVX, LLC
End Stage Kidney Disease, Chronic Kidney Diseases
The WavelinQ™ Arterio-Venous Endovascular Fistula: A Global, Post-Market Investigation
This is a global, multi-center, prospective, post-market, confirmatory, interventional, non-randomized, single-arm clinical investigation evaluating arteriovenous fistula (AVF) creation by means of the WavelinQ™ EndoAVF System in…
- Conditions
- End Stage Kidney Disease, Chronic Kidney Diseases, Kidney Failure, Kidney Insufficiency
- Trial name
- WAVE-Global (NCT04626427)
- Testing
- WavelinQ™ EndoAVF System
- Where
- 3 sites in Belgium, Greece and 1 more
- Volunteers
- 21 people
- Sponsor
- C. R. Bard
End Stage Renal Disease
Evaluation of STARgraft-3 for Hemodialysis
This study is a single site, prospective, single arm evaluation of the safety and effectiveness of the Healionics STARgraft-3 hemodialysis access graft.
- Trial name
- NCT05729620
- Testing
- Implant of STARgraft-3 shunt in the upper arm and subsequent use for hemodialysis access
- Where
- Paraguay
- Volunteers
- 21 people
- Sponsor
- Healionics Corporation
End Stage Kidney Disease (ESRD)
STARgraft (10401) Pilot
This study is a single site, prospective, single arm evaluation of the safety and effectiveness of the Healionics STARgraft (10401) hemodialysis access graft.
- Trial name
- NCT07555717
- Testing
- STARgraft (10401)
- Where
- Paraguay
- Volunteers
- 20 people
- Sponsor
- Healionics Corporation
Chronic Kidney Disease
A Study of PRT-201 Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-1)
This research study is designed to assess the safety and effectiveness of an experimental drug called PRT-201 in patients both receiving or expecting to receive dialysis who have chronic kidney disease and who are undergoing…
- Trial name
- NCT02110901
- Testing
- PRT-201
- Where
- 35 sites in United States
- Volunteers
- 349 people
- Sponsor
- Proteon Therapeutics
Hemodialysis, Clinical Assessment
Contactless Optical Monitoring of AV Access Using the PatenSee System in Outpatient Hemodialysis Patients
This is a prospective, non-interventional, single arm, international multicenter study in which up to 120 adult participants with kidney failure requiring regular hemodialysis through arteriovenous (AV) access (AV fistula or…
- Trial name
- NCT07194395
- Testing
- PatenSee System
- Where
- 2 sites in United States, Israel
- Volunteers
- 90 people
- Sponsor
- PatenSee Ltd.
Chronic Kidney Disease
Novel Endovascular Access Trial (NEAT)
The objective of this study is to evaluate the safety and efficacy of the FLEX System when used to create an arteriovenous fistula (AVF or AV fistula) percutaneously in patients with Chronic Kidney Disease (CKD) who require…
- Trial name
- NEAT (NCT02036671)
- Testing
- The FLEX System will be used to percutaneously create a fistula in CKD patients who require hemodialysis vascular access
- Where
- 9 sites in Australia, Canada and 1 more
- Volunteers
- 80 people
- Sponsor
- C. R. Bard
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
End Stage Renal Disease
Initial Safety Study of the TRUE AVC in Hemodialysis Access (TRUE AVC I Study)
Prospective, nonrandomized, single-arm, single-center, open-label, initial safety study in subjects requiring hemodialysis. Subjects will be followed with physical evaluation and ultrasound vessel imaging at days 15, 29, 57 and…
- Trial name
- NCT05567757
- Testing
- Arteriovenous conduit implant
- Where
- Panama
- Volunteers
- 11 people
- Sponsor
- Vascudyne, Inc.
End-stage Renal Disease
Xeltis Hemodialysis Access Graft: aXess Pivotal Study
A prospective, single arm, non-randomized pivotal study to evaluate the safety and performance of the Xeltis hemodialysis access graft in subjects older than 18 years with end-stage renal disease, who plan to undergo hemodialysis…
- Trial name
- NCT05473299
- Testing
- Xeltis Hemodialysis Access (aXess) graft
- Where
- 22 sites in Belgium, Germany and 7 more
- Volunteers
- 120 people
- Sponsor
- Xeltis