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

RecruitingPhase 2Ages any - anyAllBeth Israel Deaconess Medical Center
NCT06761170 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 simpl

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📋 Eligibility rules (as published)
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
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What it tests

  • Spray cryo therapy
  • Standard of Care (SOC)
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Where

1 site
Beth Israel Deaconess Medical Center
Boston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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