Pharmaceutical sponsor
TransMedics Clinical Trials
Studies where TransMedics is the lead sponsor: its pipeline by phase, what is enrolling now and where. Studies it supports as a collaborator are in the search.
In numbers
Open to volunteers: recruiting, not yet recruiting or enrolling by invitation. Active adds studies under way that have stopped recruiting.
Open to volunteers
All 5Lung Transplant
Decreasing Edema With a Novel OCS Solution Trial
This is a prospective, multicenter randomized trial of lung transplant recipients transplanted with either a DBD or DCD donor lungs.
- Trial name
- DENOVO (NCT07340710)
- Testing
- OCS Lung System, Static Cold Storage
- Volunteers
- 450 people
- Sponsor
- TransMedics
Heart Transplant
Enhancing Heart Allograft Function With the OCS Heart System Trial
This trial is designed to evaluate the safety and effectiveness of the novel OCS Solution and OCS Functional Enhancer (OFE) to support FDA approval in both DBD and DCD heart transplantation.
- Trial name
- ENHANCE (NCT07145515)
- Testing
- OCS Heart, Static Cold Storage (SCS)
- Where
- 8 sites in United States
- Volunteers
- 655 people
- Sponsor
- TransMedics
Heart Transplant
US National OCS Heart Perfusion (OHP) Registry
This Registry is a sponsor initiated, multi-center, observational post-approval registry with independent academic oversight.
- Trial name
- NCT05915299
- Testing
- OCS Heart
- Where
- 37 sites in United States
- Volunteers
- 100,000 people
- Sponsor
- TransMedics
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 Transplant
US National OCS Liver Perfusion (OLP) Registry
This Registry is a sponsor-initiated, multi-center, observational, post-approval registry with an independent academic oversight.
- Trial name
- National OLP (NCT05940857)
- Testing
- OCS Liver
- Where
- 22 sites in United States
- Volunteers
- 100,000 people
- Sponsor
- TransMedics
Completed, with results posted
All –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
Heart Transplant
Heart EXPAND Continued Access Protocol
The OCS™ Heart System will be used to preserve and assess donor hearts that do not meet current standard donor heart acceptance criteria for transplantation in this continued access protocol.
- Trial name
- NCT03835754
- Testing
- OCS Heart System
- Where
- 12 sites in United States
- Volunteers
- 75 people
- Sponsor
- TransMedics
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
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
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