Clinical trial NCT06761170: Spray Cryotherapy for the Management of Benign Central Airway Stenosis (Cryo-BAS)
Official title: Spray Cryotherapy for the Management of Benign Central Airway Stenosis (Cryo-BAS): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Stenosis of Trachea
Keywords: Stenosis of trachea
benign
spray cryotherapy
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: American Association of Broncology and Interventional Pulmonology
First posted: 2025-01-07
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Investigators propose a single center, single-blinded (patient), randomized 1:1 trial comparing SCT plus Balloon dilatation (experimental group) vs SoC alone (control group). Investigators aim to recruit 50 patients.

Study will span 2-year duration with 1 year recruitment. Follow up at 6 weeks, 3 months, 6 months, 12 months. The patient's airway will be either a laryngeal mask airway or a rigid bronchoscopy for passive venting and gas egress.

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

Primary outcomes:
measure: Need of re intervention
timeFrame: Need of re intervention in two years
Secondary outcomes:
measure: Time to re intervention
timeFrame: Two years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
References:
citation: Leong P, Bardin PG, Lau KK. What's in a name? Expiratory tracheal narrowing in adults explained. Clin Radiol. 2013 Dec;68(12):1268-75. doi: 10.1016/j.crad.2013.06.017. Epub 2013 Aug 13.