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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05948904
Other study ID # 2024-11550
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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