Cryospray Therapy for Airway Stenosis

(CRYOSTASIS Trial)

Overseen By Ramsha Hamid

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Virginia Commonwealth University

Disqualifiers: Pregnancy, Malignant stenosis, Severe COPD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: 3

Duration: 5 weeks

12 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a clinical evaluation to assess the effectiveness of cryospray therapy used in addition to current standard of care endoscopic therapies in preventing short term recurrent airway stenosis with a multicentric outcome evaluation. The investigators hypothesize that the addition of SCT to standard endoscopic treatment of benign airway stenosis will result in decreased stenosis recurrence at 6 months as estimated by quantitative radiologic assessment of the stenotic volume.

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.

Is spray cryotherapy generally safe for treating airway conditions?

Spray cryotherapy (SCT) has been shown to be a safe treatment for both benign and malignant airway diseases, with studies indicating it can be administered multiple times without significant side effects. However, some reports note potential complications like hemodynamic instability (issues with blood flow and pressure) during the procedure, so proper technique is important to minimize risks. ^{1 2 3 4 5}

How is cryospray therapy different from other treatments for airway stenosis?

Cryospray therapy is unique because it uses a noncontact method to apply liquid nitrogen, rapidly freezing and thawing tissue to cause cellular death and maintain airway patency without removing stents. This approach reduces the risk of airway fire and damage to existing stents, which can occur with other thermal ablation methods. ^{1 2 3 4 6}

Research Team

Ray Shepherd, MD

Principal Investigator

Virginia Commonwealth University

Eligibility Criteria

Adults over 18 with severe tracheal narrowing (at least half blocked) as seen on a chest CT or bronchoscopy, who are referred for endoscopic treatment of non-cancerous airway tightening. Not for pregnant individuals, those with recent pneumothorax, severe lung conditions, unstable blood pressure or heart rate, prior negative reactions to cryospray therapy, or certain anatomical issues.

Inclusion Criteria

You are capable of giving valid consent.

I am older than 18 years.

My airway is significantly narrowed by more than half.

Exclusion Criteria

I have had more than one airway surgery, not including tracheal surgery, in the past 6 months.

Inability to provide informed consent

Hemodynamic instability with systolic blood pressure <90 mmHg or heart rate > 120 beats/min, unless deemed to be stable with these values by the attending physicians

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

5 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of re-stenosis and quality of life measures

6 months

Continuous monitoring with assessments at 2 weeks, 3 months, and 6 months

Treatment Details

Interventions

• Cryospray Therapy

Trial Overview The trial is testing if adding Cryospray Therapy (SCT) to standard balloon dilation and radial incision treatments can better prevent the return of benign airway constriction within six months. Participants' airways will be measured using radiology to see if SCT makes a difference.

Participant Groups

Group I: Intervention Experimental Treatment 3 Interventions

Bronchoscopic balloon dilation with radial cuts \& truFreeze spray cryotherapy

Group II: Standard of care Active Control 2 Interventions

Bronchoscopic balloon dilation with radial cuts

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

US Endoscopy Group Inc.

Industry Sponsor

Trials

3

Recruited

340+

Findings from Research

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 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]

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]

Direct spray cryotherapy (SCT) is a safe and effective outpatient treatment for both benign and malignant airway lesions, with the ability to be repeated multiple times without significant side effects.

Proper technique and airway venting are crucial to prevent complications like barotrauma during SCT, highlighting the importance of careful administration in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current status of spray cryotherapy for airway disease. Moore, RF., Lile, DJ., Abbas, AE.[2020]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of Bronchoscopic Spray Cryotherapy and Ultra-low Temperature on Physical Properties of Metallic and Silicone Airway Stents. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Hemodynamic Instability Following Airway Spray Cryotherapy. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

The Application of Liquid Nitrogen Spray Cryotherapy in Treatment of Bronchial Stenosis. [2017]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Airway spray cryotherapy: initial outcomes from a multiinstitutional registry. [2022]

5. China pubmed.ncbi.nlm.nih.gov

Current status of spray cryotherapy for airway disease. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Treatment of Benign Tracheal Stenosis Using Endoluminal Spray Cryotherapy. [2018]