Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01615484 · ClinicalTrials.gov registry record · NA
Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability
A NA study of Cystic Fibrosis and Pulmonary Hypertension, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 24
- Enrollment target
- 2
- Study locations
NCT01615484 is a NA study of Cystic Fibrosis and Pulmonary Hypertension that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 24 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (87% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT01615484, a NA study of Cystic Fibrosis and Pulmonary Hypertension, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this research study is to learn about the safety of transplanting lungs obtained from non-heart-beating donors (NHBDs) 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 perfusion and ventilation is to learn how well the lungs work, and whether they are likely safe to transplant.
Conditions Studied
Interventions
- PROCEDURE Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™
- DEVICE STEEN Solution™
Study Locations (2)
North Carolina
- UNC-Chapel Hill - Chapel Hill
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2013-09 |
| Est. Completion | 2017-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01615484
The ClinicalTrials.gov registry entry for NCT01615484 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (87% lower). The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 8 conditions, with Cystic Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™ is the first listed.
NCT01615484 reports 2 study locations spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT01615484 about?
NCT01615484 is a clinical study titled "Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability". The purpose of this research study is to learn about the safety of transplanting lungs obtained from non-heart-beating donors (NHBDs) 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 Vitr...
What is the current status of trial NCT01615484?
This trial is currently completed. It is a NA study. The enrollment target is 24 participants. The study started on 2013-09. Estimated completion is 2017-01.
What conditions does trial NCT01615484 study?
This clinical trial studies the following conditions: Cystic Fibrosis, Pulmonary Hypertension, Chronic Obstructive Pulmonary Disease (COPD), Emphysema, Pulmonary Fibrosis.
What interventions are being tested in trial NCT01615484?
The interventions under investigation include: Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™ (PROCEDURE), STEEN Solution™ (DEVICE).
Who is sponsoring clinical trial NCT01615484?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01615484 being conducted?
This trial has 2 study locations across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cystic Fibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Exercise in Child Health
RECRUITING · NA
-
A Pilot and Feasibility Study to Evaluate High vs Low Glycemic Index Mixed Meal Tolerance Test in Adolescents and Young Adults With Cystic Fibrosis
RECRUITING · NA
-
FEED-Cystic Fibrosis (FEED-CF)
RECRUITING · NA
-
The Effects of a Low Glycemic Load Diet on Dysglycemia and Body Composition in Adults With Cystic Fibrosis-Related Diabetes
RECRUITING · NA
-
Skin-interfaced Colorimetric Bifluidic Sweat Sensor Device for the Diagnosis of Cystic Fibrosis (CF)
RECRUITING · NA
-
Lung Transplant READY CF 2: CARING CF Ancillary RCT
RECRUITING · NA
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.