An interventional study of Ex vivo cryo-ablation in Lung Cancer, sponsored by Endocision Technologies Inc.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Endocision Technologies Inc. · Not applicable, Interventional, and Device feasibility
Demonstrate the application of in-development cryogenic catheters for the ablation of pulmonary lesions.
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.
This study's planned enrollment of 10 is below the median of 60 across 5,296 interventional studies indexed under Lung Neoplasms.
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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
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.
Device: Ex 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.
Tissue temperature at 5 mm from the probe over intervention time
Measuring the temperature is and indicator of thermal cooling power and is required to confirm the design and operating specifications of the cryocatheter.
Time frame: 48 months
Tissue temperature at 10 mm from the probe over intervention time
Measuring the temperature is and indicator of thermal cooling power and is required to confirm the design and operating specifications of the cryocatheter.
Time frame: 48 months
Tissue temperature at 15 mm from the probe over intervention time
Measuring the temperature is and indicator of thermal cooling power and is required to confirm the design and operating specifications of the cryocatheter.
Time frame: 48 Months
Iceball size
Measurement of the major axis in mm of the resulting iceball to confirm the design and operating specifications of the cryocatheter
Time frame: 48 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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