This study is in progress, not accepting new patients

OCS Lung System EXPAND II Trial

a study on Lung Transplant

Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Jasleen Kukreja
Headshot of Jasleen Kukreja
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.

Official Title

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

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

Lead Scientist at UCSF

  • Jasleen Kukreja
    Professor, Surgery, School of Medicine. Authored (or co-authored) 95 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
TransMedics
ID
NCT03343535
Study Type
Interventional
Participants
At least 46 people participating
Last Updated