Spray cryotherapy with balloon dilation for benign tracheal and subglottic stenosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Christine Conley
• Email: Cconley@bidmc.harvard.edu
• Phone: 617-632-8386

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.