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NCT Number: NCT07104253

Establishing Feasibility of Transbronchial Cryoablation With an In-Development Cryoprobe: An Ex-Vivo Human Lung Model

Demonstrate the application of in-development cryogenic catheters for the ablation of pulmonary lesions.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ex vivo cryo-ablation

Device

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.

Primary outcomes

  1. Tissue temperature at 5 mm from the probe over intervention time

    Time frame: 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.

  2. Tissue temperature at 10 mm from the probe over intervention time

    Time frame: 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.

  3. Tissue temperature at 15 mm from the probe over intervention time

    Time frame: 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 outcomes

  1. Iceball size

    Time frame: 48 months

    Measurement of the major axis in mm of the resulting iceball to confirm the design and operating specifications of the cryocatheter

Sponsors and collaborators

Lead sponsor

Endocision Technologies Inc.

Industry

Collaborators

  • Centre de Recherche du Centre Hospitalier de l'Université de Montréal

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 5, 2025
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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