Interstitial Lung Disease (ILD), Lung Cancer (Diagnosis)
Conditions
Keywords
cryocathter, cryobiopsy, cryo-extraction, cryodevitalization
Brief 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.
Interventions
DEVICEDisposable Flexible Cryocatheter System
The clinicaly required bronchosopic intervention requiring the use of a cryocatheter will be done with the Disposable Celsio Flexible Cryocatheter System
Sponsors
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events rate | During the procedure until 30 days post-intervention | Adverse Events (SAEs) include pneumothorax rand bleeding, and 30-day mortality |
| Diagnostic yield | 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 |
| Procedural duration | 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) |
Countries
Canada
Contacts
CONTACTMarc Fortin, MD, MSc
Outcome results
None listed