Clinical trials: Access and Evaluation
- Condition Access and Evaluation
- Funder type Industry (pharma, biotech, devices)
- Has posted results yes
Heart Failure, Congestive Heart Failure
Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System
This is a multicenter, prospective, single-arm Continued Access study of the Optimizer Smart System with CCM therapy.
- Conditions
- Heart Failure, Congestive Heart Failure, Chronic Heart Disease, CHF
- Trial name
- FIX-HF-5CA (NCT03102437)
- Testing
- Optimizer Smart System
- Where
- 17 sites in United States
- Volunteers
- 106 people
- Sponsor
- Impulse Dynamics
End Stage Renal Disease
Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access
This study is a prospective, non-randomized, multi-center evaluation of the performance of the GORE® ACUSEAL Vascular Graft. The study will enroll patients with End-Stage Renal Disease (ESRD), who are either currently receiving…
- Trial name
- ACUSEAL (NCT01173718)
- Testing
- GORE® ACUSEAL Vascular Graft
- Volunteers
- 138 people
- Sponsor
- W.L.Gore & Associates
Vascular Access Complication
Effectiveness of the Rapid Intravascular Start (RIVS) System Versus Conventional Catheter
The study will test a hypothesis that the RIVS system will have a higher rate of successful first PIV placement compared to conventional catheter without a significant increase in complications and time of procedure.
- Trial name
- NCT00914069
- Testing
- RIVS vascular access, Conventional vascular access
- Where
- 3 sites in United States
- Volunteers
- 175 people, healthy volunteers welcome
- Sponsor
- C. R. Bard
Heart Transplant
Donor After Circulatory Death Heart CAP Trial
The Portable Organ Care System (OCS™) Heart for Resuscitating, Preserving and Assessing Hearts Donated after Circulatory Death Continued Access Protocol (OCS DCD Heart CAP)
- Trial name
- NCT04615182
- Testing
- Transplant
- Where
- 25 sites in United States
- Volunteers
- 90 people
- Sponsor
- TransMedics
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
Atrial Fibrillation
Continued Access Protocol
This Continued Access Protocol has been written to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the Arctic Front® Cryoablation System is under review.
- Trial name
- CAP-AF (NCT00889681)
- Testing
- Arctic Front Cardiac Cryoablation System
- Where
- 10 sites in United States
- Volunteers
- 81 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Mitral Regurgitation, Mitral Valve Regurgitation
Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) and COAPT CAS
The purpose of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) Trial is to confirm the safety and effectiveness of the MitraClip…
- Conditions
- Mitral Regurgitation, Mitral Valve Regurgitation, Treatment of Functional Mitral Regurgitation in Symptomatic Heart Failure Subjects, Heart Failure
- Trial name
- COAPT (NCT01626079)
- Testing
- MitraClip System
- Where
- 86 sites in United States, Canada
- Volunteers
- 776 people
- Sponsor
- Abbott Medical Devices
Complication of Renal Dialysis, End Stage Renal Disease
Trial to Evaluate the Sirolimus-Eluting Collagen Implant on AV Fistula Outcomes
The objective of this study is to evaluate efficacy and safety outcomes following use of the Sirolimus-eluting Collagen Implant (SeCI) in subjects undergoing surgical creation of an AV fistula for vascular access (index…
- Conditions
- Complication of Renal Dialysis, End Stage Renal Disease, End Stage Kidney Disease, ESRD
- Trial name
- ACCESS (NCT02513303)
- Testing
- Sirolimus, AV Fistula Surgery, Sirolimus-eluting Collagen Implant (SeCI)
- Where
- 4 sites in United States
- Volunteers
- 269 people
- Sponsor
- Vascular Therapies, Inc.
Pain
Evaluation of Risk Minimization, Assessment and Outcomes in Patients With Chronic Pain Taking Avinza
The purpose of this study is to provide information in a broad, "real world" population of chronic pain patients assessing both pain control with AVINZA as well as the potential risk for misuse and abuse.
- Trial name
- ACCESS 2008 (NCT00640042)
- Testing
- morphine sulfate extended release capsules
- Where
- 384 sites in United States, Puerto Rico
- Volunteers
- 1,570 people
- Sponsor
- Pfizer
Renal Failure, End Stage Renal Disease
Comparison of the Human Acellular Vessel (HAV) With ePTFE Grafts as Conduits for Hemodialysis
The main purpose of this study is to compare the Human Acellular Vessel (HAV) with ePTFE grafts when used for hemodialysis access.
- Conditions
- Renal Failure, End Stage Renal Disease, Hemodialysis, Vascular Access
- Trial name
- NCT02644941
- Testing
- Human Acellular Vessel (HAV), ePTFE graft
- Where
- 38 sites in United States, Germany and 4 more
- Volunteers
- 355 people
- Sponsor
- Humacyte, Inc.
Degenerative Disc Disease
Retrospective Multicenter Clinical Evaluation of Complications for Single or Multilevel VEO® Lateral Access and Interbody Fusion System and eXtreme Lateral Interbody Fusion (XLIF®) Subjects
The purpose of this retrospective clinical evaluation is to compare VEO® single or multilevel results to XLIF® single or multilevel results relative to the safety endpoints.
- Trial name
- NCT01878149
- Where
- 4 sites in United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Baxano Surgical, Inc.
Arteriovenous Graft
An Efficacy and Safety Study of SRM003 in the Treatment of Subjects Undergoing Placement of an Arteriovenous Graft to Facilitate Hemodialysis Access
A study to evaluate the efficacy of SRM003 treatment versus participating sites' standard practice treatment in extending the duration of primary patency after arteriovenous graft surgery in subjects with end-stage renal disease.
- Trial name
- NCT01806584
- Testing
- SRM003, Participating Site's standard practice
- Where
- 46 sites in United States
- Volunteers
- 32 people
- Sponsor
- Shire
Endovascular Procedures
Safety and Accuracy of the Saranas EBBMS for the Detection of Endovascular Procedure Related Bleeding Events
To evaluate the safety and accuracy of the Saranas EBBMS for the detection of access site related internal bleeding events during large-bore endovascular procedures.
- Trial name
- NCT03621202
- Testing
- Saranas Early Bird Bleed Monitoring System (EBBMS)
- Where
- 5 sites in United States
- Volunteers
- 66 people
- Sponsor
- Saranas, Inc.
Psoriasis
A Canadian Open-Label Access Program to Evaluate Adalimumab When Added to Inadequate Therapy for the Treatment of Psoriasis
To evaluate the safety profile, the effectiveness and the economic impact of adalimumab when used for the treatment of subjects with active plaque psoriasis who have not adequately responded to prior psoriasis therapy.
- Trial name
- PRIDE (NCT00513370)
- Testing
- Humira (adalimumab)
- Where
- 27 sites in Canada
- Volunteers
- 203 people
- Sponsor
- Abbott
Rheumatoid Arthritis
A Study to Evaluate Patient Characteristics and Treatment Patterns Among Rheumatoid Arthritis Patients
This is a retrospective cohort study to evaluate patient characteristics, treatment patterns including a 6-factor effectiveness proxy measure, health care resource use and associated costs among Rheumatoid Arthritis patients…
- Trial name
- NCT04047121
- Where
- United States
- Volunteers
- 1,349 people
- Sponsor
- Pfizer
Heart Failure, Congestive
PARTNERS HF: Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure
The purpose of this study is to determine the value of diagnostic data obtained from Medtronic implantable cardioverter defibrillators (ICDs) with cardiac resynchronization therapy (CRT) to evaluate cardiovascular and heart…
- Trial name
- NCT00279955
- Testing
- Cardiac Resynchronization Therapy Device
- Where
- 93 sites in United States
- Volunteers
- 1,024 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Liver Transplant
OCS Liver PROTECT Continued Access Protocol
Continued Access Protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers.
- Trial name
- NCT04186221
- Testing
- OCS Liver System
- Where
- 17 sites in United States
- Volunteers
- 74 people
- Sponsor
- TransMedics
Kidney Failure, Chronic, Renal Dialysis
Evaluating the Safety and Effectiveness of the InnAVasc Graft for Dialysis Access in Patients With Kidney Failure
The CSP-1001 study will evaluate the safety and effectiveness of the InnAVasc arteriovenous graft (AVG) when implanted in and used for hemodialysis in participants suffering from end stage renal failure (ESRD).
- Trial name
- NCT03645681
- Testing
- InnAVasc arteriovenous graft surgical implant
- Where
- 7 sites in United States
- Volunteers
- 26 people
- Sponsor
- W.L.Gore & Associates
Gather Feasibility Data and User Feedback on Use of a Device in Vivo on Pregnant Volunteers in Their 2nd and 3rd Trimester
Vscan Access R2 Feasibility Evaluation
This study is being done to evaluate if the Vscan Access R2 Ultrasound System can measure Fetal Heart Rate (FHR) in humans when compared against a reference device (GE Corometrics 170 Series Fetal Monitor), and to gather feedback…
- Trial name
- NCT03617419
- Testing
- GE VScan Access R2 Ultrasound System, GE Corometrics 170 Series Fetal Monitor
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- GE Healthcare