NCT03484455

Study to Evaluate Performance of the Organ Recovery Systems LifePort® Liver Transporter System, a Machine Perfusion System, for Liver Transplant

A Prospective Randomized Multi-Center Study of the Use of the Organ Recovery Systems LifePort® Liver Transporter (LLT) System With Vasosol® as Compared to Static Cold Storage in Orthotopic Liver Transplants (Perfusion to Improve Liver Outcomes in Transplantation)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Organ Recovery Systems, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Comparison of hypothermic machine perfusion of livers to standard of care (static cold storage).

Detailed description

Prospective, randomized, multi-center study to show safe and effective use of whole liver preservation via hypothermic machine perfusion (HMP) as compared to livers preserved by static cold storage.

Conditions

• Liver Transplantation

Interventions

Type	Name	Description
DEVICE	Hypothermic machine perfusion	Organ Recovery Systems LifePort® Liver Transporter (LLT) System and Vasosol® Machine Perfusion Solution
DEVICE	Static cold storage	Static cold storage (standard of care)

Timeline

• Start date: 2019-04-03
• Primary completion: 2022-07-12
• Completion: 2022-07-12
• First posted: 2018-03-30
• Last updated: 2022-10-07

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study