Clinical trials: Organ Preservation
Liver Preservation
Trial of the TransMedics Organ Care System™ Liver For Preserving and Assessing Donor Livers for Transplantation
A prospective, single-center controlled trial to evaluate the safety and performance of the portable Organ Care System (OCS) Liver for preservation and assessment of donor livers for transplantation.
- Trial name
- REVIVE (NCT02449694)
- Testing
- OCS Liver
- Where
- United Kingdom
- Volunteers
- 25 people
- Sponsor
- TransMedics
Organ Preservation
A Central Preservation and Assessment Service to Optimize Donor Kidney Allocation
This is a study to collect information to assess if transporting hard-to-place (HTP) donor kidneys to a central preservation and assessment facility with dedicated organ assessment capabilities increases allocation success to…
- Trial name
- OPTIMAL (NCT06263023)
- Testing
- Sub-Normothermic Machine Preservation and Assessment
- Where
- 8 sites in United States
- Volunteers
- 80 people
- Sponsor
- 34 Lives, PBC
Lung Preservation
International Randomized Study of the TransMedics Organ Care System (OCS Lung) for Lung Preservation and Transplantation
A prospective, international, multi-center, randomized controlled trial comparing preservation of donor lungs using OCS-Lung perfusion device (Treatment Group) to cold flush and storage (Control Group).
- Trial name
- INSPIRE (NCT01630434)
- Testing
- OCS Lung, Cold flush and storage
- Where
- 21 sites in United States, Australia and 7 more
- Volunteers
- 320 people
- Sponsor
- TransMedics
Chronic Kidney Disease, Acute Kidney Injury
FAST GFR: Pilot Study to Evaluate the Safety of the FAST GFR Test in Patients.
This is a single site study designed to evaluate the FAST mGFR Test™ in healthy adult volunteers, patients with varying degrees of chronic kidney disease (CKD), and patients with acute kidney injury (AKI).
- Trial name
- NCT01978314
- Testing
- 75 mg / 6 mL VFI™
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- FAST BioMedical
Liver Transplantation, Liver Preservation for Transplant
OCS Liver PROTECT Trial: Preserving and Assessing Donor Livers for Transplantation
A prospective, phased-pivotal, international randomized trial to evaluate the effectiveness of the OCS™ Liver to preserve and assess donor livers intended for transplantation.
- Trial name
- PROTECT (NCT02522871)
- Testing
- OCS™ Liver System, Control
- Where
- 20 sites in United States
- Volunteers
- 300 people
- Sponsor
- TransMedics
Tongue Neoplasms, Squamous Cell Carcinoma
Role of Neo-adjuvant Chemotherapy in Tongue Preservation in Locally Advanced Squamous Cell Carcinoma of Oral Tongue
Patients enrolled for the study, who are eligible for NACT, will undergo a pre-treatment workup comprising of Evaluation Under Anesthesia (EUA) for tumor Mapping and tissue biopsy along with a PET-CT scan.
- Conditions
- Tongue Neoplasms, Squamous Cell Carcinoma, Anterior Tongue Squamous Cell Carcinoma
- Trial name
- NCT02985255
- Testing
- Docetaxel, Cisplatin, 5FU
- Where
- India
- Volunteers
- 30 people
- Sponsor
- HealthCare Global Enterprise Ltd.
Kidney Preservation and Transportation
Prospective, Single-Arm, Study to Assess the Safety and Performance of the TB1-K Device for Organ Preservation in Donor Kidneys for Transplantation
TB1-K Device is an organ preservation and transportation system, using ultrasound technology with a cooling system to preserve the organ in optimal conditions during transport to the transplant recipient.
- Trial name
- EMERGE (NCT03600285)
- Testing
- TB1-K
- Where
- 3 sites in Spain
- Volunteers
- 32 people
- Sponsor
- Transplant Biomedicals, S.L.
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
Heart Transplant
International EXPAND Heart Pivotal Trial
To evaluate the effectiveness of the OCS™ Heart to recruit, preserve and assess donor hearts that may not meet current standard donor heart acceptance criteria (as identified above) for transplantation to potentially improve…
- Trial name
- EXPANDHeart (NCT02323321)
- Testing
- Preservation of Hearts for Transplantation
- Where
- 11 sites in United States
- Volunteers
- 75 people
- Sponsor
- TransMedics
Organ Transplant, Ischemic Reperfusion Injury
PERTRIAL - Perla® Preservation Solution
Perla® is a Cold Preservation Solution, with purpose to wash out, preserve during transport liver and kidney grafts in optimal conditions from the donor to the recipient.
- Trial name
- NCT05194306
- Testing
- Perla® Cold Preservation solution
- Where
- Spain
- Volunteers
- 11 people
- Sponsor
- Advanced Life Solutions
Lung Transplant
International EXPAND Lung Pivotal Trial
To evaluate the safety and effectiveness of the OCS™ Lung to recruit, preserve and assess donor lungs that may not meet current standard donor lung acceptance criteria for transplantation.
- Trial name
- EXPANDLung (NCT01963780)
- Testing
- OCS Lung Preservation
- Where
- 11 sites in United States, Belgium and 2 more
- Volunteers
- 79 people
- Sponsor
- TransMedics
Heart Transplant
Donors After Circulatory Death Heart Trial
To evaluate the effectiveness of the OCS Heart System to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation.
- Trial name
- NCT03831048
- Testing
- OCS Heart System, Cold Storage
- Where
- 25 sites in United States
- Volunteers
- 180 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.
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
Kidney Failure, Liver Failure, Chronic
Custodiol-N Solution Compared With Custodiol Solution in Organ Transplantation (Kidney, Liver and Pancreas)
Synopsis Title of Study A prospective, randomized, single blind multicentre phase III study on organ preservation with Custodiol-N compared with Custodiol solution in organ transplantation (kidney, liver and pancreas) Protocol…
- Conditions
- Kidney Failure, Liver Failure, Chronic, Kidney-Pancreas Failure
- Trial name
- NCT03627013
- Testing
- Custodiol-N Solution, Custodiol HTK Solution
- Where
- 4 sites in Austria
- Volunteers
- 362 people
- Sponsor
- Dr. F. Köhler Chemie GmbH