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

NCT07104253 | Not Yet Recruiting

• 1 other identifier: 2025-12805
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Lung Cancer

Keywords

Lung Cancer; Transbronchial Ablation; Cryoablation

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  48 Months

Secondary Outcomes (1)

• Iceball size

  48 months

Study Arms (1)

Ex Vivo Cryo

EXPERIMENTAL

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

Interventions

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.

Ex Vivo Cryo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing lung transplant surgery

You may not qualify if:

• Organ donors eligible to donate lungs for transplantation Healthy individuals Patients with ongoing pulmonary infection at the time of transplant

Sponsors & Collaborators

• Endocision Technologies Inc.: lead
• Centre de Recherche du Centre Hospitalier de l'Université de Montréal: collaborator

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: August 5, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share