Establishing Feasibility of Transbronchial Cryoablation With an In-Development Cryoprobe: An Ex-Vivo Human Lung Model
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ex vivo cryo-ablation.
- Who it may be relevant to
- Registry conditions: Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- 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 c
Primary outcome measures
- Tissue temperature at 5 mm from the probe over intervention time [Time frame: 48 months]
- Tissue temperature at 10 mm from the probe over intervention time [Time frame: 48 months]
- Tissue temperature at 15 mm from the probe over intervention time [Time frame: 48 Months]
Secondary outcome measures (1)
- Iceball size [Time frame: 48 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Device feasibility
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07104253 · 2025-12805