NCT06088758

Normothermic Machine Perfusion of Steatotic Livers for Expansion of Donor Organ Pool

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to assess the ability of Normothermic Machine Perfusion (NMP) to resuscitate moderately steatotic livers for transplantation in patients. This will be a single-site clinical trial placing donor livers with 30-60% macrosteatosis on NMP, and then transplanting those that meet commonly accepted viability criteria. The results of this study could lead to a trial extending NMP transplantation to severely steatotic livers, further expanding the donor organ pool.

Conditions

• Liver Transplant

Interventions

Type	Name	Description
DEVICE	Normothermic machine perfusion (NMP) of steatotic liver	Steatotic liver grafts that are selected will be run on NMP to assess quality of graft and determine whether it meets criteria for transplantation

Timeline

• Start date: 2024-02-28
• Primary completion: 2026-07-31
• Completion: 2027-07-31
• First posted: 2023-10-18
• Last updated: 2025-11-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study