Status:
RECRUITING
Cryospray Therapy for Benign Airway Stenosis
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
US Endoscopy Group Inc.
Conditions:
Stenosis Trachea
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
Spray cryo treatment of tracheal stenosis has the potential for long-lasting endoscopic management of BCAS and is used as part of routine clinical care by many physicians, but there is a relative pauc...
Eligibility Criteria
Inclusion
- Referral to interventional pulmonology or otorhinolaryngology or thoracic surgery for endoscopic management of suspected benign tracheal stenosis.
- Significant tracheal stenosis defined by stenosis ≥ 50% of tracheal lumen assessed on chest CT or previous bronchoscopy
- Able to provide informed consent.
- Age \> 18
Exclusion
- 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
- 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.
- Compromised tissue where significant ulceration or mucosal break is evident in the ablation area or adjacent organs.
- Significantly reduced tissue strength caused by prior procedure or pre-existing condition (e.g. PEG tube)
- Significantly reduced elasticity of the ablation area (e.g. Marfan's Syndrome)
- Prior complications with SCT (Spray cryotherapy)
- Contraindication to rigid bronchoscopy
- Significant tracheomalacia or alterations in cartilage integrity on CT (Computed Tomography) that would require stent placement or surgical referral.
- Greater than 1 BCAS intervention, excluding cricotracheal (tracheal surgery) resection, within 6 months before enrollment.
- Anatomical flow resistance (gas evacuation) where any procedure or anatomy proximal to the ablation site has significantly reduced or restricted the flow area of the lumen creating restriction where gas created from liquid nitrogen cannot adequately vent.
Key Trial Info
Start Date :
October 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06085209
Start Date
October 12 2023
End Date
December 30 2026
Last Update
December 10 2025
Active Locations (1)
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1
Virgnia Commonwealth University
Richmond, Virginia, United States, 23298