Evaluating a machine for preserving livers for transplantation
A Prospective Multi-Center Continued Access Protocol for the Use of the LifePort® Liver Transporter (LLT) System With Vasosol® in Orthotopic Liver Transplants (PILOT™_CA: Perfusion to Improve Liver Outcomes in Transplantation_ Continued Access Arm)
This study is testing a new machine that helps keep donated livers healthy for transplant to see if it works safely for people waiting for a liver transplant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Organ Recovery Systems, Inc. Industry-sponsored |
| Locations | 4 sites (Chicago, Illinois and 3 other locations) |
| Trial ID | NCT05574361 on ClinicalTrials.gov |
What this trial studies
This study aims to provide continued access to the LifePort® Liver Transporter System, which utilizes hypothermic machine perfusion to preserve whole explanted livers. The focus is on gathering additional safety data to support the pivotal efficacy and safety trial of this innovative system. Participants will be de novo liver transplant recipients who are actively on the UNOS waiting list. The study will assess the performance of this machine in a real-world clinical setting.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are on the UNOS waiting list for liver transplantation.
Not a fit: Patients who are multi-organ transplant recipients or have severe systemic infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this could enhance the safety and effectiveness of liver transplantation procedures.
How similar studies have performed: Other studies have shown promise with machine perfusion techniques for organ preservation, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chicago, Illinois and 3 other locations
- Northwestern Memorial Hospital — Chicago, Illinois, United States (Recruiting)
- University of Chicago Medical Center — Chicago, Illinois, United States (Recruiting)
- Rutgers New Jersey Medical School — Newark, New Jersey, United States (Recruiting)
- University of Cincinnati Medical Center — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Stan Harris
- Email: sharris@organ-recovery.com
- Phone: 847-824-2600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.