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
- Registration Number
- NCT05574361
- Lead Sponsor
- Organ Recovery Systems, Inc.
- Brief Summary
To provide continued access for the LLT system to provide additional safety data in support of the PILOT pivotal efficacy and safety trial
- Detailed Description
To provide continued access for the LLT System with Vasosol® for the preservation of whole explanted livers, thereby providing additional safety data in support of the PILOT pivotal efficacy and safety trial
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
Not provided
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Early Allograft Dysfunction (EAD) 7 days EAD defined as total bilirubin ≥ 10 mg/dL or International Normalized Ratio (INR) ≥ 1.6 or Aspartate Aminotransferase (AST) \>2000IU/L or Alanine Aminotransferase (ALT) \> 2000 IU/L
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Rutgers New Jersey Medical School
🇺🇸Newark, New Jersey, United States
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
Northwestern Memorial Hospital🇺🇸Chicago, Illinois, United StatesDaniel Borja-Cacho, MDContact