Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, G1V 4G5, Canada
NCT Number: NCT07539701
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Québec, Quebec, G1V 4G5, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The clinicaly required bronchosopic intervention requiring the use of a cryocatheter will be done with the Disposable Celsio Flexible Cryocatheter System
Time frame: 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
Time frame: During the procedure until 30 days post-intervention
Adverse Events (SAEs) include pneumothorax rand bleeding, and 30-day mortality
Time frame: From procedure to end of follow up at 2 years
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 beginning of the procedure to end of the procedure
From first bronchoscope introduction into the patient (beginning of the procedure) to last bronchoscope removal (end of the procedure)
Contact information is provided by the study sponsor or research team.
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Other
Acronym: CELSIO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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