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

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

Status: Not yet enrolling

Conditions: Interstitial Lung Disease (ILD); Lung Cancer (Diagnosis)

Treatments: Device: Disposable Flexible Cryocatheter System

Study type: Interventional

Funder types: Other

Identifiers

NCT07539701

2026-4542

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

undergoing bronchoscopic procedures using the Celsio Cryocatheter Device

Experimental group

Description:

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

Treatment:

Device: Disposable Flexible Cryocatheter System