This study is accepting new patients by invitation only

Trial to Evaluate the Safety and Effectiveness of the Portable Organ Care System (OCS™) Lung System for Recruiting, Preserving and Assessing Non-Ideal Donor Lungs for Transplantation

a study on Lung Transplant

Summary

for people ages 18-75 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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

Details

Inclusion

At least one of the following:

  • Donor PaO2/FiO2 ≤ 300 mmHg at the time of the offer; or
  • Expected cross-clamp time > 6 hours for the second lung; or
  • Donor after Cardiac Death (DCD donor); or
  • Donor age ≥ 55 years old

Keywords

Lung Transplantation portable ex-vivo lung perfusion breathing lung transplant portable OCS Lung System OCS Lung Preservation OCS

Eligibility

You can join if…

Open to people ages 18-75

  • Male or female primary double lung transplant candidate
  • Age ≥ 18 years old
  • Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information

You CAN'T join if...

  • Prior solid organ or bone marrow transplant
  • Single lung recipient
  • Chronic use of hemodialysis or renal replacement therapy for diagnosis of chronic renal dysfunction requiring dialysis
  • Participant in any other clinical or investigational trials/programs

Locations

  • University of California, San Francisco
    San Francisco California 94143 United States
  • Stanford University Medical Center
    Stanford California 94305 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
TransMedics
ID
NCT03343535
Study Type
Interventional
Last Updated
September 10, 2018