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 ↗
Who can join
Sex ALLHealthy volunteers Not acceptedYou may qualify if
- Patients with symptomatic, benign, simple stenosis of the trachea and/or subglottic space.
- Stenotic airway of diameter < 1cm.
You can't join if
- Complex stenosis, cartilage involvement (malacia or fracture).
- Patients with giant bullae (> a third of hemithorax) or bullae >3cm.
- Concurrent tracheoesophageal fistula, active tracheal malignancy.
- Presence of concomitant upper airway obstruction.
- Pregnancy
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openBeth Israel Deaconess Medical Center
Boston, Massachusetts, United States
- Adnan Majid, MD · Contact617-632-8252amajid@bidmc.harvard.edu
- Christine Conley, Healthcare Administration · Contact6176328386cconley@bidmc.harvard.edu
Recruiting
Study team
Sponsor
Beth Israel Deaconess Medical Center
Study ID 2024P000875
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.