Cryospray therapy for treating benign airway stenosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical evaluation assesses the effectiveness of cryospray therapy in conjunction with standard endoscopic therapies for preventing short-term recurrence of benign airway stenosis. The study hypothesizes that adding cryospray treatment will reduce the recurrence of stenosis at six months, as measured by radiologic assessments. The intervention includes truFreeze Spray Cryotherapy, balloon dilation, and radial incision, aiming to provide longer-lasting management of tracheal stenosis. This multicentric study seeks to fill the gap in peer-reviewed data regarding this treatment approach.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 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:

  1. Hypoxemia with need for supplemental oxygen ≥ 2L/min by nasal canula
  2. 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. Compromised tissue where significant ulceration or mucosal break is evident in the ablation area or adjacent organs.
  6. Significantly reduced tissue strength caused by prior procedure or pre-existing condition (e.g. PEG tube)
  7. 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.

Where it's running

• Virgnia Commonwealth University
  Richmond, Virginia, United States Recruiting

Study contacts

• Principal investigator: Ray Shepherd — Virginia Commonwealth University
• Study coordinator: Ramsha Hamid
• Email: ramsha.hamid@vcuhealth.org
• Phone: (804) 628-2176

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.