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)

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)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Organ Recovery Systems, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Liver Transplantation

Interventions

Type	Name	Description
DEVICE	Hypothermic Machine Perfusion	Organ Recovery Systems LifePort® Liver Transporter (LLT) System and Vasosol® Machine Perfusion Solution

Timeline

• Start date: 2022-09-19
• Primary completion: 2026-02-01
• Completion: 2027-02-28
• First posted: 2022-10-10
• Last updated: 2026-01-22

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study