CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 320 enrolled
Drug / intervention
OCS Lung +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01630434
NCT01630434N/ACompleted

Prospective, International, Multi-Center, Randomized Clinical Investigation of TransMedics Organ Care System (OCS LUNG) for Lung Preservation and Transplantation

TransMedics·interventional·Posted Jun 28, 2012·Updated Apr 4, 2023

In Brief

A clinical study evaluating OCS Lung and Cold flush and storage for Lung Preservation. Completed, enrolled 320 participants across 21 sites in 9 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Belgium, Canada, France, Germany, Italy, Spain, United Kingdom, United States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 28, 2012
Enrollment StartNov 1, 2011
Primary CompletionSep 1, 2014
Study CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 14.0 years ago

Interventions

OCS Lungdevice

OCS Lung will be used to preserve the donor lungs (Treatment Group).

Cold flush and storagedevice

Donor lungs will preserved using standard cold flush and storage