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

NCT07539701 | Not Yet Recruiting

• 1 other identifier: 2026-4542
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

cryocathter; cryobiopsy; cryo-extraction; cryodevitalization

Outcome Measures

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

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

Secondary Outcomes (3)

• Adverse events rate

  During the procedure until 30 days post-intervention

• Diagnostic yield

  From procedure to end of follow up at 2 years

• Procedural duration

  From beginning of the procedure to end of the procedure

Study Arms (1)

undergoing bronchoscopic procedures using the Celsio Cryocatheter Device

EXPERIMENTAL

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

Interventions

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

undergoing bronchoscopic procedures using the Celsio Cryocatheter Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patient undergoing a bronchoscopic procedure with planned use of a 1.7mm cryocatheter

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms; Disease; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Marc Fortin, MD, MSc

CONTACT

1-418-656-8711; marc.fortin@criucpq.ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Respirologist, MD, MSc

Study Record Dates

• First Submitted: March 15, 2026
• First Posted: April 20, 2026
• Study Start: March 23, 2026
• Primary Completion (Estimated): March 23, 2027
• Study Completion (Estimated): March 23, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

CA (1)