Spray Cryotherapy for Tracheal Stenosis

(Cryo-BAS Trial)

Overseen By Christine Conley

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Beth Israel Deaconess Medical Center

Disqualifiers: Complex stenosis, Giant bullae, Pregnancy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: Immediate

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for benign airway stenosis (narrowing of the airway) using spray cryotherapy (a treatment that uses extreme cold) combined with balloon dilatation. Researchers aim to determine if this method reduces the need for additional treatments compared to current standard methods, such as steroid injections and balloon dilatation. The study also evaluates patient experience, safety, and any changes in the airway. Individuals with simple airway narrowing that causes symptoms and an airway diameter of less than 1 cm may be eligible to participate. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that spray cryotherapy is generally safe for treating benign tracheal stenosis, a narrowing of the airway. Past studies have used it successfully to keep the airway open without major side effects. The treatment involves applying very cold liquid nitrogen to the inside of the airway to reduce the obstructing tissue.

Most participants in these studies tolerated the treatment well. Some experienced minor discomfort, but serious issues were rare. The FDA has already approved the treatment for other airway procedures, indicating its general safety. These findings may reassure those considering joining this trial about the safety of spray cryotherapy. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for tracheal stenosis?

Researchers are excited about spray cryotherapy for tracheal stenosis because it offers a unique way to treat airway narrowing. Unlike standard treatments like steroid injections, radial mucosal incisions, and balloon dilation, spray cryotherapy uses extreme cold to freeze and remove scar tissue in the trachea. This method can potentially lead to better airway healing and reduce the recurrence of narrowing. Additionally, spray cryotherapy is minimally invasive and can be a quick procedure, making it an appealing option for patients and doctors alike.

What evidence suggests that spray cryotherapy plus balloon dilatation could be effective for benign airway stenosis?

Research has shown that spray cryotherapy, one of the treatments studied in this trial, effectively treats tracheal stenosis, a condition where the airway becomes too narrow. Studies have found that spray cryotherapy helps keep the airway open in all patients without major side effects. A review found that it significantly improves breathing by reducing airway narrowing. In this trial, some participants will receive spray cryotherapy combined with balloon dilation. Another study suggested that adding spray cryotherapy to standard treatments might lower the chance of the narrowing returning within six months. These findings support spray cryotherapy as a promising treatment option for improving airway function. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals with symptomatic, benign tracheal or subglottic stenosis (narrowing of the airways) that's simple in nature and where the narrowed part of the airway is less than 1cm wide.

Inclusion Criteria

My airway is narrower than 1cm.

I have a non-cancerous narrowing in my windpipe that causes symptoms.

Exclusion Criteria

Pregnancy

I have a severe narrowing in my airway with cartilage damage.

I have large lung blisters bigger than 3cm or taking up more than a third of my lung area.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgery and receive either spray cryotherapy plus balloon dilatation or standard of care treatment

Immediate

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Follow-up at 6 weeks, 3 months, 6 months, 12 months

Long-term follow-up

Participants are monitored for the need of reintervention over a two-year period

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Spray Cryotherapy
• Standard of Care

Trial Overview

The study compares spray cryotherapy plus balloon dilatation against standard care, which includes steroid injections, radial cuts, and balloon dilatation. It aims to see if this new combination reduces the need for further interventions.

How Is the Trial Designed?

Group I: Interventional Experimental Treatment 1 Intervention

1. Stenotic lumen diameter \> 8mm: 1. Spray Cryo Therapy for 5s, repeated 3-5 cycles 2. Balloon dilation (to normal airway diameter) 2. Stenotic lumen diameter \< 8mm 1. Balloon dilation (up to 8mm diameter) 2. Spray Cryo Therapy for 5s, repeated 3-5 cycles 3) Balloon dilation (to normal airway diameter)

Group II: Control Active Control 1 Intervention

1. Steroid injection 2. Radial mucosal incision 3. Balloon dilation (to normal airway diameter)

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

American Association of Broncology and Interventional Pulmonology

Collaborator

Trials

2

Recruited

100+

Citations

1.

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 ...

2.

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 postoperative ...

3.

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 ...

4.

cureus.com

cureus.com/articles/162996-cryotherapy-for-the-treatment-of-tracheal-stenosis-a-systematic-review

Cryotherapy for the Treatment of Tracheal Stenosis

Our review demonstrates that cryotherapy for inoperable tracheal stenosis can be an acceptable alternative treatment with significant clinical improvement.

5.

journal.chestnet.org

journal.chestnet.org/article/S0012-3692(18)31993-7/fulltext

TREATMENT OF AIRWAY STENOSIS WITH ENDOLUMINAL ...

CONCLUSIONS: Our meta-analysis showed significant improvement in the degree of airway narrowing before and after treatment with endoluminal spray cryotherapy ...

6.

atsjournals.org

atsjournals.org/doi/pdf/10.1164/ajrccm-conference.2022.205.1_MeetingAbstracts.A4106?download=true

Spray Cryotherapy in Benign Tracheal Stenosis

Few studies have reported safety data and general practice patterns with this new device. Methods: A retrospective chart review was ...