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Spray Cryotherapy for the Management of Benign Central Airway Stenosis (Cryo-BAS)
Sponsor: Beth Israel Deaconess Medical Center
Summary
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.
Official title: Spray Cryotherapy for the Management of Benign Central Airway Stenosis (Cryo-BAS): A Randomized Controlled Trial
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2025-06-02
Completion Date
2027-01-15
Last Updated
2025-07-28
Healthy Volunteers
No
Conditions
Interventions
Spray cryo therapy
normal flow, 5 seconds repeated for 3-5 cycles
Standard of Care (SOC)
1. Steroid injection 2. Radial mucosal incision 3. Balloon dilation (to normal airway diameter)
Locations (1)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States