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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called cryospray therapy to determine its effectiveness for airway stenosis, a condition where the airway narrows, making breathing difficult. Researchers aim to discover if adding cryospray therapy to the usual treatment can reduce the chance of the airway narrowing again within six months. Participants will receive either the standard treatment or the standard treatment plus cryospray therapy. Individuals with significant tracheal stenosis (narrowing of the windpipe) who have been referred for endoscopic management might be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

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 cryospray therapy is safe for airway stenosis?

Research has shown that cryospray therapy is generally safe for treating airway problems. One study used it as an additional treatment for airway narrowing and reported few complications. Another study found the therapy effective and safe for both non-cancerous and cancerous airway conditions. This treatment uses liquid nitrogen to freeze and treat the affected area, and it is easy to perform. Overall, these findings suggest that cryospray therapy is well-tolerated and could be a safe option for managing airway narrowing. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about cryospray therapy for airway stenosis because it offers a new way to treat this condition by using truFreeze spray cryotherapy. Unlike the standard approach of bronchoscopic balloon dilation with radial cuts, this experimental treatment combines this method with cryotherapy, which involves applying extreme cold to target and treat affected airway tissues. This unique approach could potentially provide more precise treatment, minimize tissue damage, and improve recovery time. By integrating cryotherapy, the treatment might effectively reduce inflammation and scar formation, leading to better outcomes for patients with airway stenosis.

What evidence suggests that cryospray therapy might be an effective treatment for airway stenosis?

Research has shown that cryospray therapy yields promising results for treating airway problems. In this trial, one group of participants will receive bronchoscopic balloon dilation with radial cuts and truFreeze spray cryotherapy. Previous studies demonstrated that cryospray therapy kept the airways open in all patients, and another study found that 86.4% of patients experienced less airway narrowing after treatment. These findings suggest that cryospray therapy could help prevent the recurrence of airway narrowing when combined with standard treatments. Early evidence indicates it may enhance the effectiveness of current therapies for airway narrowing. ^{2 3 4 5}

Who Is on the Research Team?

Ray Shepherd, MD

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5384897/

Current status of spray cryotherapy for airway disease - PMC Direct spray cryotherapy (SCT) in the airway has shown promising results in the treatment of esophageal premalignant and even invasive lesions.

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

Cryospray Therapy Versus Standard of Care for Benign ... Other potential benefits include using SCT with high oxygen concentrations, improved bleeding, use on materials that may be combustible such as airway stents, ...

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. jtd.amegroups.org jtd.amegroups.org/article/view/11966/html

Current status of spray cryotherapy for airway disease - Moore Overall, 86.4% of patients had an improvement in grade of stenosis after treatment. Table 2 shows our results and compares our outcomes between patients with ...

5. 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.