StudyFinder
Cryospray Therapy Versus Standard of Care for Benign Airway Stenosis (CryoStasis)
RECRUITING
18 years and over
Inclusion Criteria:
• Referral to interventional pulmonology or ENT for endoscopic management of suspected benign tracheal stenosis.
• Significant tracheal stenosis defined by stenosis ≥ 50% of tracheal lumen assessed on chest CT or symptomatology warranting evaluation.
• Able to provide informed consent
• Age \> 18
Exclusion Criteria:
• Inability to provide informed consent.
• Pregnancy
• Known or suspected malignant central airway stenosis
• Patient has already been enrolled in this study.
• Study subject has any disease or condition that interferes with safe completion of the study including:
• Hypoxemia with need for supplemental oxygen ≥ 2L/min by nasal canula
• Recent pneumothorax in the previous 12 months
• Severe COPD (defined as a FEV1/FVC \< 70% and FEV1 \< 30% predicted) and/or severe persistent asthma.
• Hemodynamic instability with systolic blood pressure \<90 mmHg or heart rate \> 120 beats/min, unless deemed to be stable with these values by the attending physicians.
• Prior complications with SCT
• Contraindication to rigid bronchoscopy
• Significant tracheomalacia or alterations in cartilage integrity that would require stent placement or surgical referral as assessed by CT imaging.
• Greater then 1 BCAS intervention within 6 months before enrollment
DEVICE: Spray cryotherapy, DEVICE: Ballon Dilation, DEVICE: Radial Incision
Pulmonary Disease
Ankush Ratwani, MD - ankush.ratwani@vumc.org
NA
NCT04996173