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NCT01241942 · ClinicalTrials.gov registry record · NA
Phase 2 Study of Ex-vivo Perfusion and Ventilation of Lungs to Assess Transplant Suitability
A NA study, sponsored by University of North Carolina, Chapel Hill.
- Terminated
- Registry status
- NA
- Development phase
- 11
- Enrollment target
NCT01241942: Clinical Trial NA study, sponsored by University of North Carolina, Chapel Hill.
NCT01241942 is a NA study that was terminated before completion, run by University of North Carolina, Chapel Hill. The registered enrollment target is 11 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01241942, a NA study, was terminated before completion, sponsored by University of North Carolina, Chapel Hill.
- TERMINATED
- Registry status
- NA
- Development phase
- 11 participants
- Enrollment target
Study Summary
The purpose of this research study is to perfect the technique of EVLP and learn about the safety of transplanting lungs that have been ventilated (attached to a breathing machine or ventilator to deliver oxygen) and perfused with a lung perfusion solution (Steen solution™, made by Vitrolife). This ventilation and perfusion will be done outside the body (ex-vivo) in a modified cardiopulmonary bypass circuit (the kind of device used routinely during most heart surgeries). The purpose of performing ex-vivo lung perfusion and ventilation (EVLP) is to learn how well the lungs work, and whether they are likely safe to transplant.
Primary Outcome
The primary objective evaluated for this study is recipient mortality at 30 days post transplant. 30 day mortality is used as a standard research assessment to evaluate post transplant outcomes.
Interventions
- DEVICE Steen Solution™
- OTHER Conventional Lung Transplant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2010-12 |
| Est. Completion | 2013-03 |
| Phase | NA |
Why NCT01241942 stopped before completion
NCT01241942 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Steen Solution™ is the first listed.
NCT01241942 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01241942 about?
NCT01241942 is a clinical study titled "Phase 2 Study of Ex-vivo Perfusion and Ventilation of Lungs to Assess Transplant Suitability". The purpose of this research study is to perfect the technique of EVLP and learn about the safety of transplanting lungs that have been ventilated (attached to a breathing machine or ventilator to deliver oxygen) and perfused with a lung perfusion solution (Steen solution™, made by Vitrolife). This ...
What is the current status of trial NCT01241942?
This trial is currently terminated. It is a NA study. The enrollment target is 11 participants. The study started on 2010-12. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01241942?
The interventions under investigation include: Steen Solution™ (DEVICE), Conventional Lung Transplant (OTHER).
Who is sponsoring clinical trial NCT01241942?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01241942's enrollment target sits among peer trials
11 1927th of 2000 higher than 74 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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