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NCT Number: NCT07539701

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

Location contact

Marc Fortin, Md, MSc

CONTACT

[email protected]

418-656-8711

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Procedural completion rate

    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

Secondary outcomes

  1. Adverse events rate

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

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

  2. Diagnostic yield

    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

  3. Procedural duration

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Marc Fortin, MD, MSc

CONTACT

[email protected]

1-418-656-8711 ext. 4747

Sponsors and collaborators

Lead sponsor

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Other

Registry information

Acronym: CELSIO

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 20, 2026
Registry last updated
Apr 20, 2026

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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