Lung Cancer
Conditions
Keywords
Lung Cancer, Transbronchial Ablation, Cryoablation
Brief summary
Demonstrate the application of in-development cryogenic catheters for the ablation of pulmonary lesions.
Detailed description
Surgical resection is the current gold standard for curative treatment of pulmonary lesions. For patients ineligible for surgical resection, transthoracic percutaneous ablation is sometimes used. Albeit the use of minimally techniques for both surgery and ablation, these interventions are associated with a high risk of complication. To reduce associated risks, transbronchial interventions have been proposed as promising alternatives. However, currently available transbronchial ablation technologies may present significant risks of bleeding or lack clinical evidence with regards to efficacy. When considering potential alternatives, promising results have been achieved using cryotechnology for cryoablation. However, the feasibility of a transbronchial cryoablation device and its thermal performance at varying freeze-thaw cycles in a clinical setting is unknown. The investigators aim to demonstrate the application of in-development transbronchial cryogenic catheters for the ablation of pulmonary lesions. The investigators aim to confirm the design and operating specifications of an in-development cryogenic catheters for the ablation of pulmonary lesions and investigate the thermal performance of the catheter.
Interventions
DEVICEEx vivo cryo-ablation
With informed consent obtained prior to transplantation, explanted lungs from patients undergoing lung transplantation will be obtained. The organs will be placed in an acrylic box and will be perfused at a temperature of 37 Celsius degrees. The lungs will be mechanically ventilated connected by an endotracheal tube size 7 inserted in the bronchus with the balloon inflated and a silk suture providing a hermetic closure proximal to the balloon. The cryocatheter will be inserted in the lungs and cryoablation will be performed with varying freeze-thaw cycles to confirm design and operating specifications of the device.
Sponsors
Endocision Technologies Inc.
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients undergoing lung transplant surgery
Exclusion criteria
Organ donors eligible to donate lungs for transplantation Healthy individuals Patients with ongoing pulmonary infection at the time of transplant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tissue temperature at 5 mm from the probe over intervention time | 48 months | Measuring the temperature is and indicator of thermal cooling power and is required to confirm the design and operating specifications of the cryocatheter. |
| Tissue temperature at 10 mm from the probe over intervention time | 48 months | Measuring the temperature is and indicator of thermal cooling power and is required to confirm the design and operating specifications of the cryocatheter. |
| Tissue temperature at 15 mm from the probe over intervention time | 48 Months | Measuring the temperature is and indicator of thermal cooling power and is required to confirm the design and operating specifications of the cryocatheter. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Iceball size | 48 months | Measurement of the major axis in mm of the resulting iceball to confirm the design and operating specifications of the cryocatheter |
Outcome results
None listed