OCS Lung System EXPAND II Trial

Purpose

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.

Condition

  • Lung Transplantation

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
OCS Lung System
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
OCS Preservation
  • Device: OCS Lung Preservation
    OCS Lung Preservation
    Other names:
    • OCS Lung Transplant

More Details

Status
Terminated
Sponsor
TransMedics

Study Contact

Detailed Description

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