Lung Cancer (Diagnosis)CELSIONCT07539701
An Initial Experience With the Disposable Celsio Cryocatheter System for Diagnostic and Interventional Bronchoscopy
A study testing Disposable Flexible Cryocatheter System in people with Lung Cancer (Diagnosis) and Interstitial Lung Disease (ILD), run by Institut universitaire de cardiologie et de pneumologie de Québec, University Laval at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer (Diagnosis), Interstitial Lung Disease (ILD)
- What is being tested?
- Disposable Flexible Cryocatheter System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 23 Mar 2026to 23 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient undergoing a bronchoscopic procedure with planned use of a 1.7mm cryocatheter
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, G1V 4G5
Marc Fortin, Md, MSc, 418-656-8711, marc.fortin@criucpq.ulaval.ca
About this study
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.
- Being tested
- Disposable Flexible Cryocatheter System
- Keywords
- cryocathter, cryobiopsy, cryo-extraction, cryodevitalization
- Medical subject headings
- Lung Neoplasms, Disease, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disposable Flexible Cryocatheter SystemDevice
The clinicaly required bronchosopic intervention requiring the use of a cryocatheter will be done with the Disposable Celsio Flexible Cryocatheter System
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Disposable Flexible Cryocatheter System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural completion rate
Procedural completion will be defined as the completion of all planned procedure steps involving the study device, without device technical dysfunction
Measured: 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
Adverse Events (SAEs) include pneumothorax rand bleeding, and 30-day mortality
Measured: 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
Measured: 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)
Measured: From beginning of the procedure to end of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start23 Mar 2026 (estimated)
- Primary completion23 Mar 2027 (estimated)
- Study completion23 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Fortin, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07539701
- Sponsor's protocol ID
- 2026-4542
- Acronym
- CELSIO
- Status last verified
- Apr 2026
- First submitted
- 15 Mar 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Initial Experience With the Disposable Celsio Cryocatheter System for Diagnostic and Interventional Bronchoscopy
- ClinicalTrials.gov ID
- NCT07539701
- Acronym / sponsor ID
- CELSIO / 2026-4542
- Keywords
- cryocathter, cryobiopsy, cryo-extraction, cryodevitalization
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Institut universitaire de cardiologie et de pneumologie de Québec, University LavalUniversity, hospital or other
- Study start
- 23 Mar 2026 (estimated)
- Primary completion
- 23 Mar 2027 (estimated)
- Study completion
- 23 Mar 2028 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| undergoing bronchoscopic procedures using the Celsio Cryocatheter Device | Experimental | Device: Disposable Flexible Cryocatheter SystemSubject 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient undergoing a bronchoscopic procedure with planned use of a 1.7mm cryocatheter
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Disposable Flexible Cryocatheter SystemThe clinicaly required bronchosopic intervention requiring the use of a cryocatheter will be done with the Disposable Celsio Flexible Cryocatheter System | Device | undergoing bronchoscopic procedures using the Celsio Cryocatheter Device |
Primary outcome
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
3 secondary outcomes
Adverse events rate
Time frame: During the procedure until 30 days post-intervention
Diagnostic yield
Time frame: From procedure to end of follow up at 2 years
Procedural duration
Time frame: From beginning of the procedure to end of the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Disposable Flexible Cryocatheter System in people with Lung Cancer (Diagnosis) and Interstitial Lung Disease (ILD), run by Institut universitaire de cardiologie et de pneumologie de Québec, University Laval at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc Fortin, MD, MSc (1-418-656-8711 ext. 4747, marc.fortin@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural completion rate (time frame: From first bronchoscope introduction into the patient (beginning of the procedure) to last bronchoscope removal (end of the procedure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.