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

Recruiting now · Phase 2

Conditions studied: Stenosis of Trachea

In brief

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.

Key facts

Study ID

NCT06761170

Run by

Beth Israel Deaconess Medical Center

People needed

50

Starts

2025-06-02

Expected to finish

2027-01-15

Last updated by the study team

2025-07-28

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1. Patients with symptomatic, benign, simple stenosis of the trachea and/or subglottic space.
• 2. Stenotic airway of diameter < 1cm.

You may not qualify 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

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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