Cryospray Therapy for Benign Airway Stenosis

Recruiting at 2 trial locations

Overseen By Fabien Maldonado, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Pregnancy, Malignant stenosis, Severe COPD, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method called spray cryotherapy for individuals with benign airway stenosis, a condition that narrows the airway and makes breathing difficult. The goal is to determine if using this spray with standard treatments can keep the airway open longer than standard treatments alone. Participants may qualify if they have significant airway narrowing requiring endoscopic treatment. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future treatment options.

Will I have to stop taking my current medications?

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 spray cryotherapy is safe for treating benign airway stenosis?

Research has shown that spray cryotherapy (SCT) is generally safe for treating non-cancerous airway narrowing. Studies have found that SCT carries a low risk of complications. Patients have tolerated the treatment well, and it effectively clears blocked airways. This method uses liquid nitrogen to freeze tissue, promoting better healing and reducing scar tissue, which may help keep the airways open longer. Although the data comes from retrospective studies, the results are promising for SCT's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about cryospray therapy for benign airway stenosis because it offers a novel approach by using extreme cold to treat the condition. Unlike traditional methods that focus solely on mechanical dilation of the airway, this therapy involves applying cold via spray cryotherapy, which may reduce inflammation and promote healing in a way that conventional balloon dilation does not. This innovative approach could potentially enhance outcomes for patients by not only widening the airway but also improving tissue health and reducing recurrence rates.

What evidence suggests that spray cryotherapy might be an effective treatment for benign airway stenosis?

Research has shown that spray cryotherapy (SCT), tested in this trial, can help keep airways open longer in people with benign airway stenosis. One study found that SCT improved airway openness in all patients without causing major problems. This trial will compare SCT combined with standard treatments, such as bronchoscopic balloon dilation with radial cuts, to standard treatments alone. Another study suggested that using SCT along with standard treatments might lower the risk of airway narrowing again after six months. This technique uses liquid nitrogen to freeze and treat the affected area, which may lead to better healing and less scar tissue. Overall, SCT appears to be a safe and potentially effective way to manage airway stenosis. ^{1 2 3 4 6}

Who Is on the Research Team?

Fabien Maldonado, MD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with significant tracheal stenosis, which means their airway passage is narrowed by at least half. They should be referred for endoscopic treatment of suspected benign tracheal stenosis and able to consent. It's not for those with malignant stenosis, recent multiple treatments, oxygen needs above a certain level, severe lung conditions like COPD or asthma, unstable blood pressure or heart rate, cartilage issues needing surgery or a history of complications from cryotherapy.

Inclusion Criteria

My airway is significantly narrowed by more than half.

Able to provide informed consent

I am older than 18 years.

Exclusion Criteria

You have unstable blood pressure (less than 90 mmHg) or a fast heart rate (more than 120 beats per minute), unless your doctor says it's okay.

I have not had a collapsed lung in the last year.

I need extra oxygen through a nose tube at 2 liters per minute or more.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo bronchoscopic balloon dilation with radial cuts and truFreeze spray cryotherapy

1 day

1 visit (in-person)

Initial Follow-up

Participants have a thin cut CT scan and pulmonary function testing within 6 weeks post-procedure

6 weeks

1 visit (in-person)

Extended Follow-up

Participants are monitored for changes in airway patency and quality of life, with repeat CT scan and questionnaires at 6 months

6 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Ballon Dilation
• Radial Incision
• Spray cryotherapy

Trial Overview The CryoStasis trial tests spray cryotherapy (SCT), where liquid nitrogen treats the airways versus standard care involving radial incisions and balloon dilation. The goal is to see if SCT can better maintain open airways after six months compared to current methods. This study will provide more solid evidence on whether SCT leads to longer-lasting improvements in patients with non-cancerous narrowing of the breathing tubes.

How Is the Trial Designed?

Group I: Intervention Active Control 3 Interventions

Bronchoscopic Balloon Dilation with Radial Cuts \& truFreeze Spray Cryotherapy

Group II: Control Placebo Group 2 Interventions

Bronchoscopic Balloon Dilation with Radial Cuts

Spray cryotherapy is already approved in United States for the following indications:

Approved in United States as Spray cryotherapy for:

• Benign central airway stenosis
• Post-intubation stenosis
• Collagen vascular diseases
• Airway trauma
• Infectious subglottic stenosis
• Idiopathic subglottic stenosis

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Virginia Commonwealth University

Collaborator

Trials

732

Recruited

22,900,000+

University of Mississippi Medical Center

Collaborator

Trials

185

Recruited

200,000+

Published Research Related to This Trial

In a study of 22 patients undergoing spray cryotherapy (SCT) for airway stenosis, both benign and malignant conditions showed significant improvement, with a median reduction of 2 grades in stenosis after treatment.

SCT achieved a final airway patency of grade 1 in 80% of benign cases and 42% of malignant cases, demonstrating its efficacy and safety with a low morbidity rate of only 4.5%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Application of Liquid Nitrogen Spray Cryotherapy in Treatment of Bronchial Stenosis. Janke, KJ., Abbas, AE., Ambur, V., et al.[2017]

This study is the first to demonstrate that bronchoscopic spray cryotherapy (SCT) is safe for use with existing airway stents, showing no physical damage or changes in their ability to maintain diameter after multiple treatments.

SCT can be effectively applied to treat stent-associated complications without compromising the integrity of silicone or metal stents, making it a promising option for managing airway stenosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Bronchoscopic Spray Cryotherapy and Ultra-low Temperature on Physical Properties of Metallic and Silicone Airway Stents. Sharma, D., Kang, L., Shepherd, RW.[2023]

In a study of 28 patients undergoing spray cryotherapy (SCT) for obstructive airway tumors, 31% experienced severe hemodynamic complications, including hypotension and bradycardia, with some requiring cardiopulmonary resuscitation.

Despite SCT's potential advantages over other treatments, such as reduced fire risk and quick hemostasis, the procedure can lead to life-threatening complications, likely due to pulmonary venous gaseous emboli, highlighting the need for further research to balance benefits and risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemodynamic Instability Following Airway Spray Cryotherapy. Pedoto, A., Desiderio, DP., Amar, D., et al.[2019]

In a study of 26 patients with benign tracheal stenosis, spray cryotherapy (SCT) was found to be a safe treatment option, showing no significant complications and leading to improved airway caliber in all patients after treatment.

After SCT, only 15% of patients had severe stenosis (grade III or IV), a significant reduction from 88% before treatment, indicating that SCT may effectively enhance airway patency, especially for those who have not responded well to traditional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Benign Tracheal Stenosis Using Endoluminal Spray Cryotherapy. Bhora, FY., Ayub, A., Forleiter, CM., et al.[2018]

Spray cryotherapy (SCT) has been demonstrated to be a safe treatment option for patients with malignant airway tumors, with only three cases of transient hypoxia occurring out of 80 procedures performed on 27 patients.

The study emphasizes the importance of proper technique and protocols, such as ensuring adequate oxygenation and passive venting of nitrogen gas, to minimize complications during SCT procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spray cryotherapy (SCT): institutional evolution of techniques and clinical practice from early experience in the treatment of malignant airway disease. Browning, R., Turner, JF., Parrish, S.[2020]

Spray cryotherapy (SC) for treating benign airway strictures was found to be safe, with only 3.2% of patients experiencing complications, including one case of pneumothorax and one intra-operative tracheostomy.

The treatment showed significant efficacy, with airway narrowing improving from a mean score of 3.5 to 2.03 after SC, and 36.4% of patients reporting being asymptomatic at follow-up, although some patients still required additional interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of spray cryotherapy and balloon dilation for non-malignant strictures of the airway. Fernando, HC., Dekeratry, D., Downie, G., et al.[2019]

Spray cryotherapy (SCT) was performed on 80 patients with malignant airway tumors, showing a high rate of airway patency after treatment (almost all patients), and minimal blood loss during procedures, indicating its efficacy and safety in managing highly vascular tumors.

Despite the overall low complication rate, there were significant intraoperative events, including hypotension and bradycardia, and caution is advised before widespread use of SCT due to these risks, highlighting the need for further studies to confirm its benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Airway spray cryotherapy: initial outcomes from a multiinstitutional registry. Finley, DJ., Dycoco, J., Sarkar, S., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37246305/

Spray Cryotherapy for Benign Large Airway Stenosis SCT as an adjunctive treatment for BAS was associated with a low rate of complications in this retrospective multicenter cohort study.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04996173

Cryospray Therapy Versus Standard of Care for Benign ... The investigators hypothesize that the addition of SCT to standard endoscopic treatment modalities of BCAO will decrease stenosis recurrence at six months. The ...

3. jamanetwork.com jamanetwork.com/journals/jamaotolaryngology/fullarticle/2542324

Treatment of Benign Tracheal Stenosis Using Endoluminal ... Findings In this case series, spray cryotherapy was successful in improving airway patency in all patients, and no substantial intraoperative or ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06085209

Cryospray Therapy for Benign Airway Stenosis The investigators hypothesize that the addition of SCT to standard endoscopic treatment of benign airway stenosis will result in decreased stenosis recurrence ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27532803/

Treatment of Benign Tracheal Stenosis Using Endoluminal ... Spray cryotherapy was successfully used without any substantial intraoperative or postoperative complications in all patients. In a median (range) follow-up of ...

6. atsjournals.org atsjournals.org/doi/pdf/10.1164/ajrccm-conference.2023.207.1_MeetingAbstracts.A4557?download=true

A Multicenter Retrospective Cohort Study of Safety and ... A Multicenter Retrospective Cohort Study of Safety and Practice. Patterns for Spray Cryotherapy in Benign Airway Stenosis. A. Ratwani1, E. A. Schwartz2, L ...