Spray cryotherapy with balloon dilation for benign tracheal and subglottic stenosis

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

This study will test whether adding spray cryotherapy to balloon dilation reduces the need for repeat procedures in people with simple benign tracheal or subglottic stenosis compared with current standard care.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sex: All
• Sponsor: Beth Israel Deaconess Medical Center (Academic / other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT06761170 on ClinicalTrials.gov

What this trial studies

This is a single-center, single-blinded randomized phase 2 trial comparing spray cryotherapy plus balloon dilatation versus standard of care (steroid injection, radial cuts and balloon dilatation) in 50 patients with simple benign central airway stenosis. Participants are randomized 1:1 and followed at 6 weeks, 3 months, 6 months, and 12 months to measure time to reintervention, need for repeat procedures, patient-reported experience, physiological and anatomical airway changes, health care utilization, and safety. Procedures are performed under either a laryngeal mask airway or rigid bronchoscopy for passive venting and gas egress. The trial enrolls patients with symptomatic simple stenoses under 1 cm in diameter and excludes complex stenoses, cartilage involvement, active tracheal malignancy, significant pulmonary bullae, concurrent upper airway obstruction, and pregnancy.

Who should consider this trial

Good fit: Ideal candidates are adults with symptomatic, benign, simple tracheal or subglottic stenosis under 1 cm in diameter who can travel to the Boston study site and meet the other inclusion/exclusion criteria.

Not a fit: Patients with complex stenosis, cartilage involvement (malacia or fracture), active tracheal malignancy, concurrent upper airway obstruction, large pulmonary bullae, or who are pregnant are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, adding spray cryotherapy could lower the frequency of repeat airway procedures and improve breathing and quality of life for patients with simple benign tracheal stenosis.

How similar studies have performed: Small case series and observational reports suggest spray cryotherapy can be safe and provide symptomatic relief in airway disease, but randomized controlled data comparing it to standard care remain limited.

Eligibility criteria

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

Where this trial is running

Boston, Massachusetts

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

Study contacts

• Study coordinator: Christine Conley

Conditions Stenosis of Trachea; Stenosis of trachea; benign; spray cryotherapy