OCS Lung System EXPAND II Trial

TransMedics

Status: Terminated

Conditions: Lung Transplantation

Treatments: Device: OCS Lung Preservation

Study type: Interventional

Funder types: Industry

Identifiers

NCT03343535

OCS-LUN-012017

Details and patient eligibility

About

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.

Full 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

Enrollment: 46 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

OCS Preservation

Experimental group

Treatment:

Device: OCS Lung Preservation