Trials / Recruiting
RecruitingNCT06513091
US National TOP Registry
US National OCS Lung Thoracic Organ Perfusion (TOP) Registry
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 10,000 (estimated)
- Sponsor
- TransMedics · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
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 real-world setting after FDA approval in the US.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | OCS Lung | The TransMedics Organ Care System (OCS) Lung is an FDA approved portable extracorporeal lung perfusion and monitoring system. |
Timeline
- Start date
- 2025-01-23
- Primary completion
- 2034-11-01
- Completion
- 2039-11-01
- First posted
- 2024-07-22
- Last updated
- 2025-09-03
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06513091. Inclusion in this directory is not an endorsement.