An Initial Experience With the Disposable Celsio Cryocatheter System for Diagnostic and Interventional Bronchoscopy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Disposable Flexible Cryocatheter System.
- Who it may be relevant to
- Registry conditions: Lung Cancer (Diagnosis), Interstitial Lung Disease (ILD). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Interventions
- Device 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
Primary outcome measures
- Procedural completion rate [Time frame: From first bronchoscope introduction into the patient (beginning of the procedure) to last bronchoscope removal (end of the procedure)]
Secondary outcome measures (3)
- Adverse events rate [Time frame: During the procedure until 30 days post-intervention]
- Diagnostic yield [Time frame: From procedure to end of follow up at 2 years]
- Procedural duration [Time frame: From beginning of the procedure to end of the procedure]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Canada · 1 center
- Institut universitaire de cardiologie et de pneumologie de Québec — Québec
Identifiers
NCT: NCT07539701 · 2026-4542