Cryospray Therapy Versus Standard of Care for Benign Airway Stenosis (CryoStasis)
Benign central airway stenosis (BCAS) is an important cause of both pulmonary morbidity and mortality. Notable causes include post-intubation stenosis, collagen vascular diseases, airway trauma, infectious and idiopathic subglottic stenosis (iSGS). Surgery is the preferred definite option; however, the first therapeutic attempt is usually endoscopic to temporarily restore airway patency and symptomatic improvement. Several endoscopic modalities exist for treatment. Most commonly, thermal or laser therapy to make radial incisions into the stenotic lesion, followed by balloon dilation to increase the area of patency. Clinicians may also inject steroids or antineoplastic agents such as mitomycin C. All of these methods have benefits and associated risks. Symptomatic stenosis frequently reoccurs with these methods. For example, the investigators have been doing 3-4 ballon dilations procedures a week at our institution. Spray cryotherapy (SCT) is a novel FDA-cleared technique that allows for liquid nitrogen to be delivered through the working channel of a bronchoscope. Few retrospective studies exist without more robust clinical trial data to reduce the risk of bias and support its widespread use. The investigators postulate that SCT and standard of care techniques will improve airway patency volume at six months than the standard of care techniques alone. Some of the proposed advantages include improved wound healing which may translate to less scar tissue and thus improvements in airway patency for a longer duration of time.
Conditions:
🦠 Pulmonary Disease
🗓️ Study Start (Actual) 25 October 2021
🗓️ Primary Completion (Estimated) 31 December 2025
✅ Study Completion (Estimated) April 2026
👥 Enrollment (Estimated) 40
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Jackson, Mississippi, United States
📍 Nashville, Tennessee, United States
📍 Richmond, Virginia, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 19 July 2021
  • First Submitted that Met QC Criteria 6 August 2021
  • First Posted 9 August 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 2 April 2024
  • Last Update Posted 4 April 2024
  • Last Verified April 2024