TorEx Lung Perfusion System

Evaluation of the TorEx Lung Perfusion System in Clinical Lung Transplantation: A Safety Study

Lung transplantation is a life-saving and life-prolonging therapy for patients with end-stage lung disease. However, the number of patients listed for lung transplantation exceeds the number of available donor lungs, leading to long wait times, deterioration in health and death of some listed patients. One way to address this issue is to reduce the number of donor lungs that are deemed unusable (declined) for transplantation. Often, donor lungs are declined for transplantation based on questionable function or inability to fully assess the organ in the donor. Due to this reason, up to 80% of potentially suitable lungs may be discarded. As a result, ex vivo lung perfusion (EVLP) was developed.

EVLP is a technique that enables the donor lungs to function in near physiological conditions outside the body, allowing surgeons to evaluate the suitability of the donor lungs for transplantation. Using this technique, centers have reported the recovery of around 70% of donor lungs that would have otherwise been deemed unusable and discarded.

The first generation Toronto EVLP technique started as a clinical trial in 2008 and became a part of the clinical standard of care at Toronto General Hospital in 2011. Since then, many clinical studies have shown that short- and long-term outcomes of recipients who received donor lungs assessed by the Toronto EVLP system were similar to those who received donor lungs deemed suitable to go straight to transplantation.

In partnership with Traferox Technologies Inc., surgeons and research team members developed the second generation TorEx Lung Perfusion System, which addresses engineering design limitations of the original Toronto EVLP system. It optimizes the Toronto EVLP technique by combining all the necessary equipment required to perform the procedure, while placing their controls within a central location. The technique of perfusion and ventilation as well as the perfusate solution remain the same between the two EVLP systems. Prior to this study, the TorEx Lung Perfusion System has not been used in clinical human lung transplantation.

The first purpose of this study is to look at the safety of using the TorEx Lung Perfusion System in 20 consented recipients. The second purpose to compare post-transplant outcomes between recipients who received donor lungs assessed by the TorEx Lung Perfusion System and a historical cohort of recipients who received donor lungs that were assessed by the first generation Toronto EVLP system.

Study Overview

• Status: Completed
• Conditions: Lung Transplant; Ex Vivo Lung Perfusion
• Intervention / Treatment: Device: TorEx Lung Perfusion System

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • Toronto General Hospital, University Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Recipient Inclusion Criteria

• Actively listed for primary lung transplantation
• Written, informed consent provided
• 18-80 years old

Recipient Exclusion Criteria

• Re-transplantation
• Multi-organ transplantation
• Participation in another interventional trial

Donor Inclusion Criteria

• Age ≤70 years old
• Ex vivo lung perfusion clinically indicated for donor lungs

Donor Exclusion Criteria

• Age >70 years old
• Donor lungs suitable to go straight to transplantation

EVLP Transplant Suitability

• Pulmonary vein PO2 > 400mmHg
• Stability or improvement of other lung function parameters during EVLP (PVR, Compliance, Airway Pressures)
• Surgeon clinically satisfied with lung evaluation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Donor lungs assessed using TorEx Lung Perfusion System	Device: TorEx Lung Perfusion System; When donor lungs with clinical indication for EVLP are allocated to consented recipients, the lungs will be assessed using the second generation TorEx Lung Perfusion System rather than the first generation Toronto EVLP technique (standard of care).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of ISHLT Primary Graft Dysfunction Grade 3	72 hours post-transplant

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival	30 days, 1 year post-transplant
Time on ventilator	Perioperative
ICU and hospital length of stay	Perioperative
Occurrence of acute rejection	1 year post-transplant
Six minute walk test	1 year post-transplant
Forced expiratory volume - one second (FEV1 in L)	1 year post-transplant

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Laura Donahoe, MD MSc FRCSC, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2022
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): May 28, 2024

Study Registration Dates

• First Submitted: December 9, 2022
• First Submitted That Met QC Criteria: December 9, 2022
• First Posted (Actual): December 19, 2022

Study Record Updates

• Last Update Posted (Estimated): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 22-5156

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No