Cryocatheter System for Lung Cancer

(CELSIO Trial)

MF
Overseen ByMarc Fortin, MD, MSc
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new cryocatheter device that uses extremely cold temperatures to treat lung issues such as tumors or blockages. The goal is to evaluate the device's effectiveness during standard bronchoscopic procedures, which examine the airways. This device stands out because it operates without requiring a large, costly setup. Individuals scheduled for a bronchoscopy using a 1.7mm cryocatheter may be suitable candidates. As an unphased trial, this study allows patients to contribute to innovative research that could simplify and enhance future lung treatments.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Celsio Cryocatheter System is safe for bronchoscopic procedures?

Research has shown that cryobiopsy, a method similar to the Celsio Cryocatheter, is generally safe and highly accurate for diagnosing lung problems. Minor issues, such as bleeding, occur in about 10% to 20% of cases. Rare complications might include air leaks in the lung or breathing difficulties.

The Celsio Cryocatheter treats tumors and blockages in the lungs, indicating it is generally well-tolerated. The device is designed to be more convenient and easier to use than older versions.

Overall, while some risks exist, studies have demonstrated that the technology behind the Celsio Cryocatheter is a safe option for treating lung conditions.12345

Why are researchers excited about this trial?

Researchers are excited about the Celsio Cryocatheter System because it offers a novel approach to treating lung cancer through a bronchoscopic procedure called cryo-intervention. Unlike traditional treatments like surgery, chemotherapy, or radiation, which can be invasive or have significant side effects, this system utilizes extreme cold to target and destroy cancerous tissues with precision. This method not only minimizes damage to surrounding healthy tissues but also has the potential to be less painful and allow for quicker recovery times. The unique delivery method of using a catheter during a bronchoscopic procedure could make it a safer option for patients who might not be ideal candidates for more invasive treatments.

What evidence suggests that the Celsio Cryocatheter is effective for lung cancer procedures?

Research has shown that cryotherapy, which uses extreme cold, effectively treats lung conditions like tumors. Studies have found that cryotherapy is safe and works well for patients with lung cancer, especially when surgery cannot remove the cancer. In this trial, participants will undergo bronchoscopic procedures using the Celsio Cryocatheter System to treat airway blockages caused by tumors. This device offers a promising option because it does not require the large, expensive equipment that traditional methods need. Overall, evidence supports cryotherapy as a strong option for managing lung cancer symptoms and complications.12467

Are You a Good Fit for This Trial?

This trial is for people scheduled to have a bronchoscopy using a 1.7mm cryocatheter, often due to lung cancer, liver disease, or interstitial lung disease. Participants must not be pregnant or breastfeeding and must give informed consent.

Inclusion Criteria

I am having a bronchoscopy with a 1.7mm cryocatheter.

Exclusion Criteria

Current pregnancy or lactation
Lack of free and informed consent
I am having a bronchoscopy with a different size cryocatheter.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Participants undergo bronchoscopic procedures using the Celsio Cryocatheter Device

1 day
1 visit (in-person)

Follow-up

Participants are monitored for adverse events and diagnostic yield

2 years
Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

  • Disposable Celsio Cryocatheter System

Trial Overview

The study is testing the Celsio disposable flexible cryocatheter system during bronchoscopies. It aims to see how well this new device works in real-world procedures compared to existing options.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: undergoing bronchoscopic procedures using the Celsio Cryocatheter DeviceExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials
26
Recruited
6,300+

Citations

Study Details | NCT07539701 | An Initial Experience With ...

An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a ...

An Initial Experience With the Disposable Celsio Cryocatheter ...

This type of catheter is already used in clinical practice for the treatment of certain types of bronchial obstructions, including tumors, ...

Clinical Outcomes of Bronchoscopic Cryotherapy for Central ...

BC is an efficient and relatively safe intervention for patients with CAO. Our findings suggest that diabetes, respiratory failure before BC, and the absence ...

K240776 - Anthony Sirgi - accessdata.fda.gov

The Celsio Flexible Cryocatheter System is intended for cryoadhesion applications during interventional procedures such as the removal of tissue ...

Selio Medical Receives FDA Clearance for Ground- ...

The company's Pre-B. Seal Lung Biopsy Plug System is now the first FDA-cleared device specifically indicated to reduce lung biopsy-associated pneumothorax.

Utility and Safety of Bronchoscopic Cryotechniques—A ... - PMC

There is emerging data that demonstrate that cryobiopsy is safe and highly accurate in the diagnosis of thoracic malignancies. Furthermore, ...

Feasibility and safety of percutaneous cryoablation under ...

Conclusions: Cryoablation is a feasible and safe treatment for malignant lung tumors with acceptable adverse event rates. However, the mortality ...