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

Beth Israel Lahey Health

Status and phase: Enrolling; Phase 2

Conditions: Stenosis of Trachea

Treatments: Procedure: Standard of Care (SOC); Procedure: Spray cryo therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06761170

2024P000875

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Interventional

Experimental group

Description:

1. Stenotic lumen diameter \> 8mm: 1. Spray Cryo Therapy for 5s, repeated 3-5 cycles 2. Balloon dilation (to normal airway diameter) 2. Stenotic lumen diameter \< 8mm 1. Balloon dilation (up to 8mm diameter) 2. Spray Cryo Therapy for 5s, repeated 3-5 cycles 3) Balloon dilation (to normal airway diameter)

Treatment:

Procedure: Spray cryo therapy

Control

Active Comparator group

Description:

1. Steroid injection 2. Radial mucosal incision 3. Balloon dilation (to normal airway diameter)

Treatment:

Procedure: Standard of Care (SOC)