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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut universitaire de cardiologie et de pneumologie de Québec, University Laval

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: undergoing bronchoscopic procedures using the Celsio Cryocatheter DeviceExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Procedural completion rate

Procedural completion will be defined as the completion of all planned procedure steps involving the study device, without device technical dysfunction

Time frame
From first bronchoscope introduction into the patient (beginning of the procedure) to last bronchoscope removal (end of the procedure)

Secondary outcomes

1

Adverse events rate

Adverse Events (SAEs) include pneumothorax rand bleeding, and 30-day mortality

Time frame
During the procedure until 30 days post-intervention
2

Diagnostic yield

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 procedure to end of follow up at 2 years
3

Procedural duration

From first bronchoscope introduction into the patient (beginning of the procedure) to last bronchoscope removal (end of the procedure)

Time frame
From beginning of the procedure to end of the procedure

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: