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

Condition(s) studied

Investigational drug(s) / intervention(s)

Disposable Flexible Cryocatheter System: The clinicaly required bronchosopic intervention requiring the use of a cryocatheter will be done with the Disposable Celsio Flexible Cryocatheter System

Study summary

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

Primary outcome measure(s)

• Procedural completion rate — From first bronchoscope introduction into the patient (beginning of the procedure) to last bronchoscope removal (end of the procedure)
  Procedural completion will be defined as the completion of all planned procedure steps involving the study device, without device technical dysfunction

Trial sites (1)

More Institut universitaire de cardiologie et de pneumologie de Québec, University Laval trials in Canada

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