Lung TransplantNCT05656404
TorEx Lung Perfusion System
A study testing TorEx Lung Perfusion System in people with Lung Transplant and Ex Vivo Lung Perfusion, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Transplant, Ex Vivo Lung Perfusion
- What is being tested?
- TorEx Lung Perfusion System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 6 Dec 2022to 28 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Toronto General Hospital, University Health Network
Toronto, Ontario, M5G 2C4
About this study
Official title: 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.
Read more
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.
- Conditions
- Lung Transplant, Ex Vivo Lung Perfusion
- Being tested
- TorEx Lung Perfusion System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TorEx Lung Perfusion SystemDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Donor lungs assessed using TorEx Lung Perfusion System | Experimental | Not described Receives: Device: TorEx Lung Perfusion System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ISHLT Primary Graft Dysfunction Grade 3
Measured: 72 hours post-transplant
Secondary outcomes (6)
Overall survival
Measured: 30 days, 1 year post-transplant
Time on ventilator
Measured: Perioperative
ICU and hospital length of stay
Measured: Perioperative
Occurrence of acute rejection
Measured: 1 year post-transplant
Six minute walk test
Measured: 1 year post-transplant
Forced expiratory volume - one second (FEV1 in L)
Measured: 1 year post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start6 Dec 2022
- Primary completion31 May 2023
- Study completion28 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TransplantStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Donahoe, MD MSc FRCSC, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656404
- Sponsor's protocol ID
- 22-5156
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2022
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the TorEx Lung Perfusion System in Clinical Lung Transplantation: A Safety Study
- ClinicalTrials.gov ID
- NCT05656404
- Acronym / sponsor ID
- 22-5156
- Conditions
- Lung Transplant, Ex Vivo Lung Perfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 6 Dec 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 28 May 2024 (actual)
- First posted
- 19 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Donor lungs assessed using TorEx Lung Perfusion System | Experimental | Device: TorEx Lung Perfusion System |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TorEx Lung Perfusion SystemWhen 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). | Device | Donor lungs assessed using TorEx Lung Perfusion System |
Primary outcome
Incidence of ISHLT Primary Graft Dysfunction Grade 3
Time frame: 72 hours post-transplant
6 secondary outcomes
Overall survival
Time frame: 30 days, 1 year post-transplant
Time on ventilator
Time frame: Perioperative
ICU and hospital length of stay
Time frame: Perioperative
Occurrence of acute rejection
Time frame: 1 year post-transplant
Six minute walk test
Time frame: 1 year post-transplant
Forced expiratory volume - one second (FEV1 in L)
Time frame: 1 year post-transplant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Donahoe, MD MSc FRCSC principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TorEx Lung Perfusion System in people with Lung Transplant and Ex Vivo Lung Perfusion, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ISHLT Primary Graft Dysfunction Grade 3 (time frame: 72 hours post-transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.