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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Interstitial Lung Disease (ILD); Lung Cancer (Diagnosis)
• Intervention / Treatment: Device: Disposable Flexible Cryocatheter System

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marc Fortin, MD, MSc; Phone Number: 4747 1-418-656-8711; Email: marc.fortin@criucpq.ulaval.ca

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1V 4G5
      • Institut Universitaire de cardiologie et de pneumologie de Quebec
      • Contact: Marc Fortin, Md, MSc; Phone Number: 418-656-8711; Email: marc.fortin@criucpq.ulaval.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: undergoing bronchoscopic procedures using the Celsio Cryocatheter Device; 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Study record dates

Study Major Dates

• Study Start (Estimated): March 23, 2026
• Primary Completion (Estimated): March 23, 2027
• Study Completion (Estimated): March 23, 2028

Study Registration Dates

• First Submitted: March 15, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: cryobiopsy; cryocathter; cryo-extraction; cryodevitalization
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pathological Conditions, Signs and Symptoms; Lung Neoplasms; Disease; Lung Diseases, Interstitial
• Other Study ID Numbers: 2026-4542

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No