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RecruitingNAINTERVENTIONAL

Defining a Technique for the Use of Cryogenic Catheters for Biopsy and Ablation for the Diagnostic and Treatment of Pulmonary Lesions: An Ex-Vivo Human Lung Model Study.

This study aims to improve how we diagnose and treat lung problems, like growths or changes in the lung tissue. Currently, often the best way to get a useful tissue sample or remove a lung lesion is with surgery. However, surgery can come with risks and a longer recovery time. This research is exploring a less invasive method using a special cryo catheter – a tiny tube that uses very cold temperatures. This catheter is guided into the lungs through the airways (transbronchial) to either take small tissue samples (cryobiopsy) or remove small problem areas (cryoablation). The study is not done on living patients, but on donated human lung tissue in a lab, to develop and perfect the technique. The hope is to make these procedures safer and gentler for people in the future.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Enrolment target
200
Start
03 Nov 2023
Estimated completion
01 Apr 2027

What is this study about?

When doctors need to figure out what's going on in someone's lungs, or sometimes treat a problem, they often need to take a tiny piece of lung tissue to look at under a microscope. This is called a biopsy. For some lung problems, surgery is also the best way to remove a growth. While these surgical methods are very effective, they can sometimes lead to issues like air leaks, infections, or a longer stay in hospital.

To make things easier and safer for patients, doctors are always looking for less invasive ways to do these procedures. One promising area uses `cryotechnology` – a method that uses very cold temperatures. This study is focused on developing and refining a technique that uses a `cryogenic catheter`. Imagine a very thin, flexible tube that can be guided into your lungs through your airways without needing a big cut. This tube then uses extreme cold to either take a small tissue sample (this is a `cryobiopsy`) or remove a small unwanted area (`cryoablation`).

The important thing to know about this particular study is that it's not being done on living people. Instead, the researchers are using donated human lung tissue in a laboratory setting. This allows them to carefully test and perfect the technique, making sure it's as effective and safe as possible before it might eventually be considered for use in patients. The main goal is to create a clear, step-by-step guide for using this advanced cryo method to help improve lung diagnosis and treatment in the future, with the aim of reducing complications and speeding up recovery for patients.

Key takeaways

  • This study is developing a new, gentler way to diagnose and treat lung problems.
  • It uses very cold temperatures (`cryo`) through a thin tube (`catheter`) inserted via the airways.
  • The research is being done in a lab using donated human lung tissue, not on living patients.
  • The aim is to make future lung biopsies and treatments safer and less invasive.
  • Potential future benefits include fewer surgical complications and faster recovery for patients.

Who may be eligible?

This study is specific because it's being done in a lab, not with living patients. Researchers need human lung tissue to develop their new technique. They will be using lung tissue from people who are undergoing a lung transplant operation.

This means that people who are healthy and not having a lung transplant cannot take part. Also, if someone is donating organs but their lungs are not suitable for transplant due to their health, that lung tissue would also not be used for this study. The study doesn't have an upper age limit, meaning donated lung tissue from adults of any age, from 18 years upwards, could be used. All genders are included.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you a living patient looking to join a trial to treat your lung condition? (If yes, this study is not for you.)
  2. Are you currently undergoing a lung transplant? (If so, your donated lung tissue might be used for research, with consent.)
  3. Are you at least 18 years old?
  4. Are you healthy and not having a lung transplant? (If yes, you cannot participate in this specific study.)
Answer every question to see your result.

What does participation involve?

This particular study is not looking for volunteers to participate directly. It's a laboratory study, meaning the research is carried out using donated human lung tissue. Therefore, there are no appointments, medications, scans, or follow-up visits for individuals. Your involvement would not be required for this type of research.

Potential risks and benefits

Since this study is conducted `ex-vivo` (meaning `outside the body` using donated human lung tissue), there are no direct risks or benefits to living individuals. The potential benefit of this research is for future patients. By perfecting this technique in the lab, it could lead to safer, less invasive ways to diagnose and treat lung conditions, reducing the need for more major surgeries and potentially lowering associated complications in the future. As no individual patients are involved, there is no right to withdraw for a participant.

Locations (1)

  • CHUM
    Verified postcode
    Montreal, Canada· Recruiting

Common questions

What is 'cryo' technology?

Cryo technology uses very cold temperatures, like intense frost, to either freeze and remove tiny pieces of tissue or to destroy small unwanted areas.

What does 'transbronchial' mean?

Transbronchial means 'through the airways.' In this study, it refers to guiding a thin tube (catheter) into the lungs through the natural air passages, without needing surgery involving cuts.

Is this study being done on people?

No, this study is done in a lab using human lung tissue that has been donated, usually from people undergoing lung transplants. No living patients are involved.

What is the goal of this research?

The main goal is to create a clear, step-by-step guide for doctors to safely and effectively use new 'cryo' tools (catheters) to get samples and treat lung issues in the future, making it less invasive for patients.

When might this new technique be available for patients?

This is early-stage research in the lab. If successful, it would still need to go through further studies before it could become a standard treatment for patients. This process can take several years.

How to find out more

Moishe Liberman, MD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Defining a Technique for the Use of Cryogenic Catheters for …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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