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International Randomized Study of the TransMedics Organ Care System (OCS Lung) for Lung Preservation and Transplantation

NCT01630434 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2023-04-04

Study results available
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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

  • Lung Preservation

Interventions

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

Sponsors & Collaborators

  • TransMedics

    lead INDUSTRY

Principal Investigators

  • Abbas Ardehali, MD · Ronald Reagan Medical Center, UCLA

  • Dirk van Raemodonck, MD · UZ Leuven, Belgium

  • Gregor Warnecke, MD · Hannover Medical Center, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2014-09-30
Completion
2016-04-30

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • France
  • Germany
  • Italy
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01630434 on ClinicalTrials.gov