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International EXPAND Lung Pivotal Trial

NCT01963780 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2022-07-07

Study results available
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Summary

To evaluate the safety and effectiveness of the OCS™ Lung to recruit, preserve and assess donor lungs that may not meet current standard donor lung acceptance criteria for transplantation.

Conditions

  • Lung Transplant

Interventions

DEVICE

OCS Lung Preservation

Sponsors & Collaborators

  • TransMedics

    lead INDUSTRY

Principal Investigators

  • Abbas Ardehali, MD · University of California, Los Angeles

  • Dirk Van Raemdonck, MD, PhD · University of Leuven Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2016-11-22
Completion
2018-04-30

Countries

  • United States
  • Belgium
  • Germany
  • Spain

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 NCT01963780 on ClinicalTrials.gov