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Cryo Biopsy/Ablation for Lung Disease (CT0129 Trial)

N/A

Recruiting

Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients undergoing lung transplant surgery

Be older than 18 years old

Must not have

Organ donor ineligible to donate lungs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new tool for removing or destroying abnormal growths in the lungs.

Who is the study for?

This trial is for patients who are undergoing lung transplant surgery. It's not open to individuals who can't donate their lungs or those who are healthy without any lung disease.

What is being tested?

The study is testing a new technique using cryogenic catheters for biopsy and treatment of lung lesions, aiming to establish a standard method in an ex-vivo (outside the body) human lung model.

What are the potential side effects?

Since this is an ex-vivo study, meaning it's conducted on lungs outside the body, there aren't direct side effects like those seen in living patients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for or have had a lung transplant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot donate my lungs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Freezing Time

Measure of Pleural breakage (Absent or Present)

Model of cryogen

+2 more

Secondary study objectives

Blood loss and complication

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Ex Vivo CryoExperimental Treatment1 Intervention

Multiple procedures will be performed to each model in order to accomplish the objectives of the study. Tissue samples will be taken from the models and images will be performed. This will allow us to determine which configuration is the optimal for obtaining the more effective and stable models that could offer the best quality specimens as well.

0 / 2Eligibility criteria met