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Not yet recruiting Not applicable NCT07539701

An Initial Experience With the Disposable Celsio Cryocatheter System for Diagnostic and Interventional Bronchoscopy

No applicable phase (e.g. observational)
Conditions: Lung Cancer (Diagnosis) Interstitial Lung Disease (ILD)

Sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

trial.available_in: БГ
Overview
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.
Who can participate
Inclusion Criteria: \- Patient undergoing a bronchoscopic procedure with planned use of a 1.7mm cryocatheter Exclusion Criteria: * 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
Interventions
Disposable Flexible Cryocatheter System
DEVICE
Locations 1
Canada (1)
Institut universitaire de cardiologie et de pneumologie de Québec
Québec , Quebec
Technical details
Status
Not yet recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
23.03.2026
Completion date
23.03.2028
Registry ID
NCT07539701
Source
clinicaltrials.gov
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