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

Phase 2

Not yet recruiting

• Conditions: Stenosis of Trachea

• Registration Number: NCT06761170
• Lead Sponsor: Beth Israel Deaconess Medical Center

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.

Study Timeline

• Study First Submitted: 2024-12-23
• Study First Submitted QC: 2024-12-30
• Study First Posted: 2025-01-07
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-17
• Study Start: 2025-05-15
• Primary Completion: 2027-01-15
• Study Completion: 2027-01-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Need of re intervention	Need of re intervention in two years	Number of patients that require new intervention for the benign airway stenosis.

Secondary Outcome Measures

Name	Time	Method
Time to re intervention	Two years	Time it takes in days for a patient to need a re intervention for the benign airway stenosis after treatment.