Spray Cryotherapy for the Management of Benign Central Airway Stenosis (Cryo-BAS)

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.

NCT Number	NCT06761170
Lead Sponsor	Beth Israel Deaconess Medical Center Collaborators: American Association of Broncology and Interventional Pulmonology
Conditions	Stenosis of Trachea
Enrollment	50 participants
Start Date	2025-06-02
Primary Completion	2027-01-15 (estimated)
Study Completion	2027-01-15 (estimated)
Updated on ClinicalTrials.gov	2025-07-28