Actively Recruiting
Spray Cryotherapy for the Management of Benign Central Airway Stenosis (Cryo-BAS)
Led by Beth Israel Deaconess Medical Center · Updated on 2025-07-28
50
Participants Needed
1
Research Sites
84 weeks
Total Duration
On this page
Sponsors
B
Beth Israel Deaconess Medical Center
Lead Sponsor
A
American Association of Broncology and Interventional Pulmonology
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Spray Cryotherapy for the Management of Benign Central Airway Stenosis (Cryo-BAS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with symptomatic, benign, simple stenosis of the trachea and/or subglottic space.
- Stenotic airway diameter less than 1 cm.
You will not qualify if you...
- Complex stenosis or cartilage involvement such as malacia or fracture.
- Presence of giant bullae larger than one third of the hemithorax or bullae greater than 3 cm.
- Concurrent tracheoesophageal fistula or active tracheal malignancy.
- Presence of other upper airway obstruction.
- Pregnancy.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
C
Christine Conley
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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