RecruitingPhase 2NCT06761170

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

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


Sponsor

Beth Israel Deaconess Medical Center

Enrollment

50 participants

Start Date

Jun 2, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Inclusion Criteria2

  • \. Patients with symptomatic, benign, simple stenosis of the trachea and/or subglottic space.
  • \. Stenotic airway of diameter < 1cm.

Exclusion Criteria5

  • Complex stenosis, cartilage involvement (malacia or fracture).
  • Patients with giant bullae (> a third of hemithorax) or bullae >3cm.
  • Concurrent tracheoesophageal fistula, active tracheal malignancy.
  • Presence of concomitant upper airway obstruction.
  • Pregnancy

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Interventions

PROCEDURESpray cryo therapy

normal flow, 5 seconds repeated for 3-5 cycles

PROCEDUREStandard of Care (SOC)

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


Locations(1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

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NCT06761170