40 Participants Needed

Cryospray Therapy for Benign Airway Stenosis

Recruiting at 2 trial locations
AR
LJ
BS
FM
Overseen ByFabien Maldonado, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Vanderbilt University Medical Center
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

Benign central airway stenosis (BCAS) is an important cause of both pulmonary morbidity and mortality. Notable causes include post-intubation stenosis, collagen vascular diseases, airway trauma, infectious and idiopathic subglottic stenosis (iSGS). Surgery is the preferred definite option; however, the first therapeutic attempt is usually endoscopic to temporarily restore airway patency and symptomatic improvement. Several endoscopic modalities exist for treatment. Most commonly, thermal or laser therapy to make radial incisions into the stenotic lesion, followed by balloon dilation to increase the area of patency. Clinicians may also inject steroids or antineoplastic agents such as mitomycin C. All of these methods have benefits and associated risks. Symptomatic stenosis frequently reoccurs with these methods. For example, the investigators have been doing 3-4 ballon dilations procedures a week at our institution. Spray cryotherapy (SCT) is a novel FDA-cleared technique that allows for liquid nitrogen to be delivered through the working channel of a bronchoscope. Few retrospective studies exist without more robust clinical trial data to reduce the risk of bias and support its widespread use. The investigators postulate that SCT and standard of care techniques will improve airway patency volume at six months than the standard of care techniques alone. Some of the proposed advantages include improved wound healing which may translate to less scar tissue and thus improvements in airway patency for a longer duration of time.

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 data supports the effectiveness of this treatment for benign airway stenosis?

Spray cryotherapy (SCT) has shown promise in managing benign airway strictures by potentially reducing fibrosis (scar tissue formation) and the need for further interventions, according to initial results. Although evidence is limited, SCT has been used effectively to relieve symptoms in airway obstructions, suggesting it may help in similar conditions.12345

Is spray cryotherapy safe for treating airway conditions?

Spray cryotherapy (SCT) has been used to treat airway conditions, but there have been reports of significant hemodynamic complications (issues with blood flow and pressure) during its use. While SCT is considered a potential therapy for maintaining airway patency, its safety, particularly regarding the integrity of airway stents, has not been fully established.12567

How is spray cryotherapy different from other treatments for benign airway stenosis?

Spray cryotherapy (SCT) is unique because it uses ultra-low temperatures to treat airway stenosis without direct contact, potentially reducing complications like granulation tissue and fibrosis that are common with other endoscopic therapies. This non-invasive approach may also allow stents to remain in place during treatment, unlike thermal ablation, which carries risks of airway fire and damage to stents.23567

Research Team

Maldonado [142102] | Vanderbilt-Ingram ...

Fabien Maldonado, MD

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

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.
See 1 more

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 need extra oxygen through a nose tube at 2 liters per minute or more.
I have not had a collapsed lung in the last year.
See 9 more

Timeline

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)

Treatment Details

Interventions

  • Ballon Dilation
  • Radial Incision
  • Spray cryotherapy
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: InterventionActive Control3 Interventions
Bronchoscopic Balloon Dilation with Radial Cuts \& truFreeze Spray Cryotherapy
Group II: ControlPlacebo Group2 Interventions
Bronchoscopic Balloon Dilation with Radial Cuts

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

๐Ÿ‡บ๐Ÿ‡ธ
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

Find a Clinic Near You

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+

Findings from Research

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.
Airway spray cryotherapy: initial outcomes from a multiinstitutional registry.Finley, DJ., Dycoco, J., Sarkar, S., et al.[2022]
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.
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.
Treatment of Benign Tracheal Stenosis Using Endoluminal Spray Cryotherapy.Bhora, FY., Ayub, A., Forleiter, CM., et al.[2018]

References

Airway spray cryotherapy: initial outcomes from a multiinstitutional registry. [2022]
Hemodynamic Instability Following Airway Spray Cryotherapy. [2019]
Treatment of Benign Tracheal Stenosis Using Endoluminal Spray Cryotherapy. [2018]
Spray cryotherapy (SCT): institutional evolution of techniques and clinical practice from early experience in the treatment of malignant airway disease. [2020]
Feasibility of spray cryotherapy and balloon dilation for non-malignant strictures of the airway. [2019]
Effect of Bronchoscopic Spray Cryotherapy and Ultra-low Temperature on Physical Properties of Metallic and Silicone Airway Stents. [2023]
The Application of Liquid Nitrogen Spray Cryotherapy in Treatment of Bronchial Stenosis. [2017]