This clinical trial is intended for patients awaiting an interventional bronchoscopy procedure where the use of a cryocatheter is considered. This type of catheter is already used in clinical practice for the treatment of certain types of bronchial obstructions, including tumors, granulomas, and for foreign bodies extractions. This catheter uses extremely cold temperatures offering unique advantages compared to heat-based technologies. Different types of reusable and single-use cryocatheters are actually available on the market. This type of device requires the use of expensive and bulky consoles operating with heavy gas tanks, resulting in high maintenance costs. A Quebec, Canada based company has developed a cryocatheter that combines procedural efficacy with practical considerations in mind. The Celsio cryocatheter operates without a console and is designed to accommodate the bronchscopist through the different types of cryogenic procedures. This study aims to generate meaningful, real-world evidence without interfering with standard clinical care. The collected data will serve to characterize the device's performance profile, identify best practices for its use, and provide data for the design of future prospective comparative studies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
30
The clinicaly required bronchosopic intervention requiring the use of a cryocatheter will be done with the Disposable Celsio Flexible Cryocatheter System
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, Canada
Procedural completion rate
Procedural completion will be defined as the completion of all planned procedure steps involving the study device, without device technical dysfunction
Time frame: From first bronchoscope introduction into the patient (beginning of the procedure) to last bronchoscope removal (end of the procedure)
Adverse events rate
Adverse Events (SAEs) include pneumothorax rand bleeding, and 30-day mortality
Time frame: During the procedure until 30 days post-intervention
Diagnostic yield
According to the Delphi Consensus Definition of Diagnostic Yield and Recommandations for Patient-centered Study Deisgns of the ATS/ACCP Research Statemen
Time frame: From procedure to end of follow up at 2 years
Procedural duration
From first bronchoscope introduction into the patient (beginning of the procedure) to last bronchoscope removal (end of the procedure)
Time frame: From beginning of the procedure to end of the procedure
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