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Active Not Recruiting
NCT05574361
Continued Access Study to Evaluate Performance of the Organ Recovery Systems _LifePort® Liver Transporter System, a Machine Perfusion System, for Liver Transplant (PILOT™_CA)
Conditions: Liver Transplantation
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 385
Sponsor: Organ Recovery Systems, Inc.
Location: Northwestern Memorial Hospital Chicago Illinois
Summary
To provide continued access for the LLT system to provide additional safety data in support of the PILOT pivotal efficacy and safety trial
Eligibility Criteria
* ≥18 years of age.
* Active on the United Network for Organ Sharing (UNOS) waiting list for liver transplantation.
* De novo liver transplant recipient.
* Written informed consent required.
Exclusion Criteria:
* Subject is a multi-organ transplant recipient.
* Subject is antibodies blood group (ABO) liver incompatible.
* Subject has severe systemic infection.
* Subject is Human Immunodeficiency Virus (HIV) positive.
* Subject has acute/fulminant liver failure.
* Subject is pregnant.
Source: ClinicalTrials.gov (NCT05574361). StuddyBuddy aggregates publicly available trial information.
