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

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to compare spray cryotherapy plus balloon dilatation versus current standard of Care (SoC - steroid injection, radial cuts and balloon dilatation) in patients with benign airway stenosis with simple stenosis. The main question\[s\] investigators aim to answer are: 1. What is the need for reintervention and time to reintervention in participants with benign airway stenosis with simple stenosis who receive spray cryotherapy plus balloon dilatation versus standard of care alone? 2. To evaluate patient experience, physiological, anatomical changes, health care utilization and safety of the SCT plus balloon dilatation versus standard of care alone. Researchers will compare spray cryotherapy plus balloon dilatation versus current standard of Care (SoC - steroid injection, radial cuts and balloon dilatation) in patients with benign airway stenosis with simple stenosis to see if it reduces the need of re intervention. Participants will surgery and receive one of the two interventions.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+