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. (CT0129)

Centre hospitalier de l'Université de Montréal (CHUM)

Status: Enrolling

Conditions: Lung Diseases

Treatments: Diagnostic Test: Cryo Ex Vivo

Study type: Interventional

Funder types: Other

Identifiers

NCT05948904

2024-11550

Details and patient eligibility

About

Developing a standardized methodology for the use of novel cryogenic catheters for transbronchial cryobiopsy and cryoablation of pulmonary lesions.

Full description

Surgical lung biopsy (SLB) and surgical resection are the current gold standard for both tissue sampling and ablation of pulmonary lesions. Albeit the use of minimally invasive surgical techniques (VATS), these interventions are frequently associated with complications which include: prolonged air leak, pneumonia, prolonged length of stay in the intensive care unit as well as an increased mortality rate which is influenced by the nature (elective vs non-elective) of the case. To reduce trauma to patients, transbronchial interventions are becoming increasingly popular. However, current techniques have only been demonstrated in humans for lung biopsy and often provide lesser quality specimens than SLB. Promising results have been achieved using cryotechnology but a standardized technique has yet to be established.

To demonstrate the potential for transbronchial interventions using cryo, we aim to develop a standardized technique for transbronchial cryobiopsy and cryoablation of pulmonary lesions using a human ex-vivo model.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing lung transplant surgery

Exclusion criteria

• Organ donor ineligible to donate lungs
• Healthy individuals

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Ex Vivo Cryo

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Cryo Ex Vivo