Actively Recruiting
Cryospray Therapy for Benign Airway Stenosis
Led by Virginia Commonwealth University · Updated on 2025-12-10
12
Participants Needed
1
Research Sites
167 weeks
Total Duration
On this page
Sponsors
V
Virginia Commonwealth University
Lead Sponsor
U
US Endoscopy Group Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a clinical evaluation to assess the effectiveness of cryospray therapy used in addition to current standard of care endoscopic therapies in preventing short term recurrent airway stenosis with a multicentric outcome evaluation. The investigators hypothesize that the addition of SCT to standard endoscopic treatment of benign airway stenosis will result in decreased stenosis recurrence at 6 months as estimated by quantitative radiologic assessment of the stenotic volume.
CONDITIONS
Official Title
Cryospray Therapy for Benign Airway Stenosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Referral to interventional pulmonology, otorhinolaryngology, or thoracic surgery for endoscopic management of suspected benign tracheal stenosis
- Significant tracheal stenosis defined as 50% or more narrowing of the tracheal lumen shown by chest CT or previous bronchoscopy
- Able to provide informed consent
- Age over 18 years
You will not qualify if you...
- Unable to provide informed consent
- Pregnancy
- Known or suspected malignant central airway stenosis
- Already enrolled in this study
- Conditions interfering with safe study completion including:
- Need for supplemental oxygen 2 liters/min or more
- Pneumothorax within the past 12 months
- Severe COPD (FEV1/FVC less than 70% and FEV1 less than 30% predicted) or severe persistent asthma
- Unstable blood pressure below 90 mmHg systolic or heart rate above 120 bpm unless stable
- Significant tissue ulceration or mucosal breaks in the ablation area or nearby organs
- Reduced tissue strength from prior procedures or conditions (e.g., PEG tube)
- Reduced tissue elasticity in the ablation area (e.g., Marfan's Syndrome)
- Prior complications with spray cryotherapy
- Contraindication to rigid bronchoscopy
- Significant tracheomalacia or cartilage problems on CT requiring stent or surgery
- More than one prior benign central airway stenosis intervention (excluding cricotracheal resection) within 6 months before enrollment
- Anatomical flow resistance limiting gas evacuation near the ablation site
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Virgnia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
Research Team
R
Ramsha Hamid
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here