TerminatedNot Applicable

OCS Lung System EXPAND II Trial

Stopped: Enrollment in EXPAND II was stopped June 24, 2019 as a result of the FDA approval for the EXPAND indication. Therefore, no additional sites or subjects were enrolled after that time.

United States46 participantsStarted 2018-03-12

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Patient Survival

Timeframe: 30 days post-transplantation or initial hospital discharge post-transplantation, a mean of 41.5 days post-transplant

Donor Lung Utilization Rate

Timeframe: Immediately at Transplantation

Trial details

NCT IDNCT03343535

SponsorTransMedics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-08-27

Results submitted2023-12-19

View on ClinicalTrials.gov More Lung Transplantation trials