Angel Cooler for Lung Disease

Overseen By Luis Angel

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Declined universal consent

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device called the Angel Cooler, which keeps donated lungs cool and oxygenated before full processing. The researchers aim to assess the device's effectiveness in maintaining lung quality by monitoring temperature, pressure, and oxygen levels. It is designed for lungs removed from donors and awaiting transfer to pathology. Donors willing to have their lungs used in this study are ideal participants. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance lung preservation techniques.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Angel Cooler device is safe for use on explanted lungs?

Research has shown that keeping donor lungs cool at about 10°C is generally safe. Studies have found that this method does not damage the lungs. Even when stored this way for up to 24 hours, the lungs still function well after transplantation.

The Angel Cooler is designed to maintain lungs at slightly lower temperatures, between 4-8°C, while providing 100% oxygen and maintaining pressure. Although specific data on this exact method is not yet available, the similar practice at 10°C suggests it might also be safe.

This trial is a feasibility study, meaning it is in the early stages of testing. Prospective participants should know that the researchers are still collecting safety data. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Angel Cooler because it introduces a novel approach to preserving donor lungs after explantation. Traditional methods rely on cold storage to keep lungs viable, but the Angel Cooler uses a unique cooling technique with oxygen and positive pressure to maintain lung functionality while they are outside the body. This innovative approach could potentially improve the success rate of lung transplants by better preserving lung tissue during the critical time between donation and transplantation.

What evidence suggests that the Angel Cooler is effective for lung preservation?

Research has shown that cooling donor lungs can improve outcomes after a transplant. One study found that maintaining lungs at cooler temperatures, such as 10°C, is safe and does not negatively affect short-term or intermediate results. Another study showed that survival rates were similar whether lungs were preserved using traditional methods or newer cooling techniques. These cooling methods aim to protect the lungs by reducing damage while they are outside the body. In this trial, researchers will test the Angel Cooler on explanted lungs to assess its function in providing cooling oxygen and positive pressure. Although limited data exists on the Angel Cooler, the concept is that keeping lungs cool with oxygen and pressure might help them stay healthier until transplantation. ^{3 4 6 7 8}

Who Is on the Research Team?

Luis Angel, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for individuals with lung disease. Specific eligibility criteria are not provided, so it's important to contact the study organizers for detailed information on who can participate.

Inclusion Criteria

Subjects who have signed Universal Consent are eligible for participation

Subjects willing to sign the Universal Consent for the use of their lungs in this study

Exclusion Criteria

Explanted lungs of those who have not signed the Universal Consent (UC) or who have declined participation in the UC will be excluded.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Procedure

The Angel Cooler is used to preserve explanted lungs by maintaining them at a specific temperature and pressure for 15-20 minutes.

15-20 minutes

1 visit (in-person)

Follow-up

Participants are monitored for the functionality of the device on Day 1.

1 day

What Are the Treatments Tested in This Trial?

Interventions

• Angel Cooler

Trial Overview The 'Angel Cooler' system is being tested to see if it can effectively monitor temperature and oxygen levels while keeping donated lungs cool and ventilated before transplant.

How Is the Trial Designed?

Group I: Explanted Lungs Experimental Treatment 1 Intervention

After the lungs are explanted from the recipient donor, they will be connected to the "Angel Cooler" via a tracheostomy tube or special adaptor to assess the function of this device in providing cooling oxygen and positive pressure to keep the lungs inflated while on the back table. The lungs will be hooked up to the cooling machine for 15-20 minutes. During this time, investigators will monitor the airway temperature, pressure and oxygen concentration continuously during the entire preservation time. Once these measures are obtained and synced to a corresponding computer, investigators will then disconnect the lungs from the device and continue the standard procedure of sending them to pathology where they will be discarded per usual in lung transplantation.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40686680/

Long-term outcomes of the international EXPAND trial ... Findings: Overall survival was similar between the EXPAND and control cohorts; 5-year overall survival was 68.1% versus 66.5%, respectively (P = ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05898776

NCT05898776 | 10°C vs 4°C Lung Preservation RCT The primary outcome of the study is incidence of ISHLT Primary Graft Dysfunction Grade 3 at 72 hours. Post-transplant outcomes will be followed for one year.

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/resp.14721

Advances in lung transplantation: 60 years on - Paraskeva However, two recent series present very clear data showing LTx outcomes from over 70 year old donors match those seen from donors less than 70 ...

4. frontierspartnerships.org frontierspartnerships.org/journals/transplant-international/articles/10.3389/ti.2024.12310/full

The Advent of Semi-Elective Lung Transplantation ... The primary outcome of this study was the incidence of Primary Graft Dysfunction (PGD) grade 3 at 72 h. Results were compared to a contemporary ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39817344/

Prolonged Preservation of up to 24 Hours at 10 °C Does ... Prolonged static preservation of donor lungs at 10°C for up to 24 hours is safe and does not impair short-intermediate outcomes after lung transplantation.

6. evidence.nejm.org evidence.nejm.org/doi/abs/10.1056/EVIDoa2300008

Extension of Cold Static Donor Lung Preservation at 10°C Extension of cold static preservation times at 10°C appears to be safe and has the potential to improve transplantation logistics and performance.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11888839/

Prolonged Preservation of up to 24 Hours at 10 °C Does Not ... Extended preservation of donor lungs at 10 °C is safe and does not negatively affect donor organ quality. Even prolonged storage at 10 °C for up to 24 hours ...

8. paragonixtechnologies.com paragonixtechnologies.com/lungguard

Advancing Donor Lung Preservation | Paragonix Important Safety Information. Indications for Use. The Paragonix LUNGguard® System is intended to be used for the static hypothermic preservation of lungs ...