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Stenosis of TracheaProcedurePhase 2

What this study is

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.

What's being tested

  • Spray cryo therapy

    Intervention · PROCEDURE

    normal flow, 5 seconds repeated for 3-5 cycles

  • Standard of Care (SOC)

    Intervention · PROCEDURE

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

Study details

Official title
Spray Cryotherapy for the Management of Benign Central Airway Stenosis (Cryo-BAS): A Randomized Controlled Trial
Sponsor
Beth Israel Deaconess Medical Center
Conditions
Stenosis of Trachea
Enrolling
50 people
Starts
2025-06-02
Est. completion
2027-01-15
Design
Single-blind, randomized, parallel groups, Phase 2
Record
View on ClinicalTrials.gov ↗