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NCT01630434 · ClinicalTrials.gov registry record · NA
International Randomized Study of the TransMedics Organ Care System (OCS Lung) for Lung Preservation and Transplantation
A NA study, sponsored by TransMedics.
- Completed
- Registry status
- NA
- Development phase
- 320
- Enrollment target
NCT01630434: Completed NA study, sponsored by TransMedics.
NCT01630434 is a NA study that has completed, run by TransMedics. The registered enrollment target is 320 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01630434, a NA study, has completed, sponsored by TransMedics.
- COMPLETED
- Registry status
- NA
- Development phase
- 320 participants
- Enrollment target
Study 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).
Primary Outcome
This composite is a single outcome measure. Primary graft dysfunction is graded on a scale of 0 to 3 according to the 2005 ISHLT PGD grading consensus. Grade 0 is considered the least severe and grade 3 is considered a more severe outcome.
Interventions
- DEVICE OCS Lung
- DEVICE Cold flush and storage
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 320 participants |
| Start Date | 2011-11 |
| Est. Completion | 2016-04 |
| Phase | NA |
What the finished NCT01630434 record still lists
NCT01630434 is an interventional study that assigns participants to a tested intervention. The registered 320 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which OCS Lung is the first listed.
NCT01630434 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01630434 about?
NCT01630434 is a clinical study titled "International Randomized Study of the TransMedics Organ Care System (OCS Lung) for Lung Preservation and Transplantation". 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).
What is the current status of trial NCT01630434?
This trial is currently completed. It is a NA study. The enrollment target is 320 participants. The study started on 2011-11. Estimated completion is 2016-04.
What interventions are being tested in trial NCT01630434?
The interventions under investigation include: OCS Lung (DEVICE), Cold flush and storage (DEVICE).
Who is sponsoring clinical trial NCT01630434?
This trial is sponsored by TransMedics, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01630434's enrollment target sits among peer trials
320 315th of 2000 higher than 1,680 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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