Clinical trials: Organ Perfusion
Heart Failure
Study of Organ Perfusion With Custodiol-N Solution Compared With Custodiol Solution in Heart Transplantation
The objective of this investigation is to demonstrate non-inferiority in outcome of Custodiol-N against Custodiol in heart transplantation.
- Trial name
- NCT02869022
- Testing
- Custodiol-N, Custodiol, organ perfusion for heart transplantation
- Where
- 9 sites in Austria, Germany
- Volunteers
- 105 people
- Sponsor
- Dr. F. Köhler Chemie GmbH
Heart Transplantation
Study of Organ Perfusion in Heart Transplantation in Children
The goal of this prospective randomized single blind multicenter phase II study is to compare organ perfusion with Custodiol-N and Custodiol in heart transplantation in children of all ages (birth to <18 years) being listed on…
- Trial name
- NCT06032195
- Testing
- Custodiol-N, Custodiol
- Where
- 3 sites in Germany
- Volunteers
- 15 people
- Sponsor
- Dr. F. Köhler Chemie GmbH
Lung Transplantation
OCS Lung System EXPAND II Trial
To evaluate the safety and effectiveness of the OCS™ Lung System to recruit, preserve and assess non-ideal donor lungs that may not meet current standard donor lung acceptance criteria for transplantation.
- Trial name
- NCT03343535
- Testing
- OCS Lung Preservation
- Where
- 14 sites in United States
- Volunteers
- 46 people
- Sponsor
- TransMedics
Lung Diseases
Increasing Lung Transplant Availability Using Normothermic Ex Vivo Lung Perfusion (EVLP) at a Dedicated EVLP Facility
The objective of this study is to evaluate the safety and effectiveness of the Centralized Lung Evaluation System (CLES) in enabling evaluation of potential donor lungs not otherwise used for transplant into subjects with end…
- Trial name
- NCT03641677
- Testing
- Centralized Lung Evaluation System, Lung Transplant
- Where
- 13 sites in United States
- Volunteers
- 174 people
- Sponsor
- Lung Bioengineering Inc.
Lung Transplantation
OCS™ Lung TOP Registry For Donor Lungs for Transplantation
Single-arm, prospective, multi-center, post-approval U.S. registry
- Trial name
- TOP (NCT03639025)
- Testing
- OCS Lung System
- Where
- 18 sites in United States
- Volunteers
- 458 people
- Sponsor
- TransMedics
End Stage Liver DIsease, Liver Failure
Bridge to HOPE: Hypothermic Oxygenated Perfusion Versus Cold Storage Prior to Liver Transplantation
This is a prospective, multi-center, controlled, randomized, pivotal study to evaluate the safety and effectiveness of the VitaSmart™ Liver Machine Perfusion System by comparing clinical outcomes in patients undergoing liver…
- Trial name
- NCT05045794
- Testing
- VitaSmart™Liver Machine Perfusion System, Static cold storage
- Where
- 15 sites in United States
- Volunteers
- 228 people
- Sponsor
- Bridge to Life Ltd.
Lung Transplant
US National TOP Registry
The objective of this Registry is to collect short and long-term post-transplant clinical outcome data of all donor lungs preserved and assessed on the OCS Lung System and to document the performance of the OCS device in the…
- Trial name
- NCT06513091
- Testing
- OCS Lung
- Where
- 7 sites in United States
- Volunteers
- 10,000 people
- Sponsor
- TransMedics
Liver Transplantation
Study to Evaluate Performance of the Organ Recovery Systems LifePort® Liver Transporter System, a Machine Perfusion System, for Liver Transplant
Comparison of hypothermic machine perfusion of livers to standard of care (static cold storage).
- Trial name
- PILOT™ (NCT03484455)
- Testing
- Hypothermic machine perfusion, Static cold storage
- Where
- 9 sites in United States
- Volunteers
- 142 people
- Sponsor
- Organ Recovery Systems, Inc.
Heart Failure
Randomized Study of Organ Care System Cardiac for Preservation of Donated Hearts for Eventual Transplantation
The purpose of the study is to compare survival of both patients and newly transplanted hearts following heart transplantation among patients who were transplanted with donated hearts preserved on ice and those who were…
- Trial name
- PROCEEDII (NCT00855712)
- Testing
- Organ Care System, Cold Cardioplegia Solution
- Where
- 11 sites in United States, France and 2 more
- Volunteers
- 128 people
- Sponsor
- TransMedics
Aortic Aneurysm, Abdominal
Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft Clinical Study
The Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft Single-Center Study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® p-Branch® and Zenith® Fenestrated AAA…
- Trial name
- FENP (NCT01652235)
- Testing
- Zenith® p-Branch® or Zenith® Fenestrated AAA Endovascular Graft
- Where
- 2 sites in United States
- Volunteers
- 28 people
- Sponsor
- Cook Research Incorporated
Liver Transplantation
Continued Access Study to Evaluate Performance of the Organ Recovery Systems _LifePort® Liver Transporter System, a Machine Perfusion System, for Liver Transplant (PILOT™_CA)
To provide continued access for the LLT system to provide additional safety data in support of the PILOT pivotal efficacy and safety trial
- Trial name
- PILOT™_CA (NCT05574361)
- Testing
- Hypothermic Machine Perfusion
- Where
- 5 sites in United States
- Volunteers
- 385 people
- Sponsor
- Organ Recovery Systems, Inc.