Suspended

A Single Center Pilot Study for Cold Oxygen Lung Preservation and Ventilation With the "Angel Cooler"

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What is being tested

Angel Cooler

Device
Who is being recruted

Lung Diseases

+ Respiratory Tract Diseases
Over 18 Years
See all eligibility criteria
How is the trial designed

Device Feasibility Study

Interventional
Study Start: January 2025
See protocol details

Summary

Principal SponsorNYU Langone Health
Last updated: December 13, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2025Actual date on which the first participant was enrolled.

This study focuses on a new method called the Angel Lung Cooler, which is designed to preserve lungs that are not being transplanted by keeping them at a specific cold temperature during the process. The goal is to ensure the lungs remain in optimal condition by monitoring and maintaining the right temperature and pressure levels. This study is particularly important as it could lead to better outcomes in lung transplantation, ensuring that lungs stay viable for longer periods during transport, which could improve the success rates of transplants. In the study, the Angel Cooler device is used in the operating room right after the lungs are removed during a transplant. The removed lungs are connected to the device to check how well it can maintain the correct temperature and pressure to keep the lungs properly inflated. This process takes between 5 to 20 minutes. After this test, the lungs are disconnected from the device and prepared for further examination in the pathology department. The study evaluates how effectively the Angel Cooler can maintain these conditions, which is crucial for the future of lung preservation in transplants.

Official TitleA Single Center Pilot Study for Cold Oxygen Lung Preservation and Ventilation With the "Angel Cooler" 
NCT06286319
Principal SponsorNYU Langone Health
Last updated: December 13, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Device Feasibility Study
These studies test whether a new medical device (like a tool or piece of equipment) is safe and practical to use. They're usually small and focus on how the device works rather than how well it treats a condition.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Lung Diseases
Respiratory Tract Diseases
Criteria

Inclusion Criteria: * Age at least 18 years * 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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
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.

Device that provides cooled oxygen (between 4-8°C) directly to the lung airways along with external cooling to lung surfaces using cold preservation solutions.
Study Objectives
Primary Objectives

The main outcome is a description of the function of the device (functional/non-functional).

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
NYU Langone HealthNew York, United StatesSee the location
SuspendedOne Study Center
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