Trials / Completed
CompletedNCT03641677
Increasing Lung Transplant Availability Using Normothermic Ex Vivo Lung Perfusion (EVLP) at a Dedicated EVLP Facility
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 174 (actual)
- Sponsor
- Lung Bioengineering Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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 stage, survival-limiting lung disease in need of lung transplantation. This will be accomplished by evaluating subject survival at the later of 12 months or hospital discharge post-transplant.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Centralized Lung Evaluation System | Assessment of allograft lung for transplant suitability |
| PROCEDURE | Lung Transplant | Orthotopic single or double lung transplantation. |
Timeline
- Start date
- 2019-01-15
- Primary completion
- 2023-12-18
- Completion
- 2024-01-18
- First posted
- 2018-08-22
- Last updated
- 2024-11-12
Locations
13 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03641677. Inclusion in this directory is not an endorsement.