About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Patient undergoing a bronchoscopic procedure with planned use of a different size cryocatheter (eg 1.1 or 2.4mm)
Current pregnancy or lactation
Lack of free and informed consent
Trial design
Single group
Treatments tested in this trial
Disposable Flexible Cryocatheter System
DeviceThe clinicaly required bronchosopic intervention requiring the use of a cryocatheter will be done with the Disposable Celsio Flexible Cryocatheter System
Treatment groups
Trial outcomes
Primary outcomes
Procedural completion rate
Procedural completion will be defined as the completion of all planned procedure steps involving the study device, without device technical dysfunction
Secondary outcomes
Adverse events rate
Adverse Events (SAEs) include pneumothorax rand bleeding, and 30-day mortality
Diagnostic yield
According to the Delphi Consensus Definition of Diagnostic Yield and Recommandations for Patient-centered Study Deisgns of the ATS/ACCP Research Statemen
Procedural duration
From first bronchoscope introduction into the patient (beginning of the procedure) to last bronchoscope removal (end of the procedure)
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: