Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| undergoing bronchoscopic procedures using the Celsio Cryocatheter Device | Experimental | Subject with a clinically required bronchoscopic intervention planned with the use of a cryocathter (cryobiopsy or cryo-extraction or cryo-devitalization) will undergo the procedure with the Celso cryocathter device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Disposable Flexible Cryocatheter System | Device | The clinicaly required bronchosopic intervention requiring the use of a cryocatheter will be done with the Disposable Celsio Flexible Cryocatheter System |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural completion rate | Procedural completion will be defined as the completion of all planned procedure steps involving the study device, without device technical dysfunction | From first bronchoscope introduction into the patient (beginning of the procedure) to last bronchoscope removal (end of the procedure) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events rate | Adverse Events (SAEs) include pneumothorax rand bleeding, and 30-day mortality | During the procedure until 30 days post-intervention |
| Diagnostic yield | According to the Delphi Consensus Definition of Diagnostic Yield and Recommandations for Patient-centered Study Deisgns of the ATS/ACCP Research Statemen |
Not provided
Inclusion Criteria:
- Patient undergoing a bronchoscopic procedure with planned use of a 1.7mm cryocatheter
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marc Fortin, MD, MSc | Contact | 1-418-656-8711 | 4747 | marc.fortin@criucpq.ulaval.ca |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut universitaire de cardiologie et de pneumologie de Québec | Québec | Quebec | G1V 4G5 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| From procedure to end of follow up at 2 years |
| Procedural duration | From first bronchoscope introduction into the patient (beginning of the procedure) to last bronchoscope removal (end of the procedure) | From beginning of the procedure to end of the procedure |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D004194 | Disease |
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided