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
Jasleen Kukreja

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 Transplantationportable ex-vivo lung perfusionbreathing lung transplantportable OCS Lung SystemOCS Lung PreservationOCS

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 accepting new patients
    San FranciscoCalifornia94143United States
  • Stanford University Medical Center accepting new patients
    StanfordCalifornia94305United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
TransMedics
ID
NCT03343535
Study Type
Interventional
Last Updated