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

Spray Cryotherapy for the Management of Benign Central Airway Stenosis (Cryo-BAS): A Randomized Controlled Trial

Who can join

All ages · All sexes

Inclusion Criteria:

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

Exclusion Criteria:

1. Complex stenosis, cartilage involvement (malacia or fracture).
2. Patients with giant bullae (\> a third of hemithorax) or bullae \>3cm.
3. Concurrent tracheoesophageal fistula, active tracheal malignancy.
4. Presence of concomitant upper airway obstruction.
5. Pregnancy

About the study

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 is being tested

• Spray cryo therapy (procedure)
• Standard of Care (SOC) (procedure)

Sponsor: Beth Israel Deaconess Medical Center · Participants: 50 · Started: Jun 2, 2025

Contact the study team

• Christine Conley · Phone: 617-632-8386

Official record on ClinicalTrials.gov — NCT06761170

Locations in the U.S.

Conditions

• Tracheal Stenosis

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.