Trials / Completed
CompletedNCT01630434
International Randomized Study of the TransMedics Organ Care System (OCS Lung) for Lung Preservation and Transplantation
Prospective, International, Multi-Center, Randomized Clinical Investigation of TransMedics Organ Care System (OCS LUNG) for Lung Preservation and Transplantation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 320 (actual)
- Sponsor
- TransMedics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | OCS Lung | OCS Lung will be used to preserve the donor lungs (Treatment Group). |
| DEVICE | Cold flush and storage | Donor lungs will preserved using standard cold flush and storage |
Timeline
- Start date
- 2011-11-01
- Primary completion
- 2014-09-01
- Completion
- 2016-04-01
- First posted
- 2012-06-28
- Last updated
- 2023-04-04
- Results posted
- 2022-07-07
Locations
21 sites across 9 countries: United States, Australia, Belgium, Canada, France, Germany, Italy, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT01630434. Inclusion in this directory is not an endorsement.