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.

Lung Diseases Clinical Trial

— CT0129  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05948904
• Other study ID #: 2024-11550
• Status: Recruiting
• Phase: N/A
• Start date: November 3, 2023
• Est. completion date: April 1, 2027

Study information

• Verified date: November 2023
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: Moishe Liberman, MD
• Phone: 514-890-8000
• Email: moishe.liberman[@]umontreal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 1, 2027
• Est. primary completion date: April 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing lung transplant surgery

Exclusion Criteria:

• Organ donor ineligible to donate lungs

• Healthy individuals

Related Conditions & MeSH terms

• Lung Diseases

Intervention

Diagnostic Test:
• Cryo Ex Vivo
Lungs from patients undergoing lung transplantation after their removal from the recipient patient with previous informed consent signed before transplantation will be obtained. The organs will be placed in an acrylic box and will be kept at a temperature of 37 Celsius degrees. The lungs will be mechanically ventilated connected by an endotracheal tube size 8 inserted in the bronchus with the balloon inflated and a silk suture providing a hermetic closure proximal to the balloon. Tissue samples will be taken from the models and images will be performed.

Locations

Country	Name	City	State
Canada	CHUM	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of Pleural breakage (Absent or Present)	Develop a standardized methodology for the use of novel cryoprobes for transbronchial lung biopsies and ablation of pulmonary lesions	48 months
Primary	Temperature of ice ball at center; Temperature of ice ball at periphery; Temperature of ice ball at varying distances from ice ball	Develop a standardized methodology for the use of novel cryoprobes for transbronchial lung biopsies and ablation of pulmonary lesions	48 months
Primary	Model of cryogen	Develop a standardized methodology for the use of novel cryoprobes for transbronchial lung biopsies and ablation of pulmonary lesions	48 months
Primary	Freezing Time	Develop a standardized methodology for the use of novel cryoprobes for transbronchial lung biopsies and ablation of pulmonary lesions	48 months
Primary	Size of resected specimen	Develop a standardized methodology for the use of novel cryoprobes for transbronchial lung biopsies and ablation of pulmonary lesions	48 months
Secondary	Blood loss and complication	Feasibility of transbronchial lung cryobiopsy and cryoablation	48 months