Cryospray Therapy Versus Standard of Care for Benign Airway Stenosis (CryoStasis)

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Aug 6, 2021

Keywords

ClinConnect Summary

The CryoStasis trial is studying a new treatment called spray cryotherapy (SCT) for people with benign central airway stenosis (BCAS), a condition where the airway becomes narrowed, making it hard to breathe. This trial aims to see if SCT can help improve airway function better than standard treatments, which often include procedures like balloon dilation and laser therapy. SCT uses cold liquid nitrogen to help heal the airway, potentially leading to less scar tissue and longer-lasting results.

To be eligible for the trial, participants need to be over 18 years old and have significant airway narrowing as determined by a CT scan or related symptoms. They should be referred for treatment by a lung or ear, nose, and throat specialist. However, individuals who are pregnant, have certain severe breathing issues, or have specific conditions that could complicate the study will not be able to participate. If chosen for the trial, participants can expect to receive either the new SCT treatment or the standard care and will be monitored to see how well their airways improve over a six-month period.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Referral to interventional pulmonology or ENT for endoscopic management of suspected benign tracheal stenosis.
• • 2. Significant tracheal stenosis defined by stenosis ≥ 50% of tracheal lumen assessed on chest CT or symptomatology warranting evaluation.
• • 3. Able to provide informed consent
• • 4. Age \> 18
• Exclusion Criteria:
• • 1. Inability to provide informed consent.
• • 2. Pregnancy
• • 3. Known or suspected malignant central airway stenosis
• • 4. Patient has already been enrolled in this study.
• 5. Study subject has any disease or condition that interferes with safe completion of the study including:
• • 1. Hypoxemia with need for supplemental oxygen ≥ 2L/min by nasal canula
• • 2. Recent pneumothorax in the previous 12 months
• • 3. Severe COPD (defined as a FEV1/FVC \< 70% and FEV1 \< 30% predicted) and/or severe persistent asthma.
• • 4. 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.
• • 5. Prior complications with SCT
• • 6. Contraindication to rigid bronchoscopy
• • 7. Significant tracheomalacia or alterations in cartilage integrity that would require stent placement or surgical referral as assessed by CT imaging.
• • 8. Greater then 1 BCAS intervention within 6 months before enrollment