Registry for lung transplant outcomes using the OCS Lung System
US National OCS Lung Thoracic Organ Perfusion (TOP) Registry
This study is tracking how well lung transplants work for patients who received donor lungs preserved with a new device called the OCS Lung System to see if it improves outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Sex | All |
| Sponsor | TransMedics Industry-sponsored |
| Locations | 7 sites (Phoenix, Arizona and 6 other locations) |
| Trial ID | NCT06513091 on ClinicalTrials.gov |
What this trial studies
This registry aims to collect both short and long-term clinical outcome data from lung transplant recipients who have received donor lungs preserved and assessed using the OCS Lung System. The study will document the performance of the OCS device in real-world settings following its FDA approval in the United States. By gathering comprehensive data, the registry seeks to enhance understanding of lung transplant outcomes and the effectiveness of the OCS technology.
Who should consider this trial
Good fit: Ideal candidates for this registry are all individuals who have undergone lung transplantation.
Not a fit: Patients who have not received a lung transplant will not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could improve lung transplant outcomes and inform best practices for the use of the OCS Lung System.
How similar studies have performed: While this registry approach is not novel, it builds on previous successful registries that have documented transplant outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
All lung transplant recipients
Where this trial is running
Phoenix, Arizona and 6 other locations
- St. Joseph's Hospital & Medical Center — Phoenix, Arizona, United States (Recruiting)
- Stanford University School of Medicine — Stanford, California, United States (Recruiting)
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
- Duke University — Durham, North Carolina, United States (Recruiting)
- Baylor Scott & White Research Institute — Dallas, Texas, United States (Recruiting)
- Baylor College of Medicine — Houston, Texas, United States (Recruiting)
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Julia Church
- Email: jdeane@transmedics.com
- Phone: 9782893546
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.