Cryospray therapy for treating benign airway stenosis

Cryospray Therapy for Benign Airway Stenosis: a Randomized Pilot Study

This study is testing a new cryotherapy treatment for people with benign airway narrowing to see if it works better than standard care methods.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Vanderbilt University Medical Center (Academic / other)
• Locations: 3 sites (Jackson, Mississippi and 2 other locations)
• Trial ID: NCT04996173 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of spray cryotherapy compared to standard care methods for patients with benign central airway stenosis. The study involves endoscopic interventions, including balloon dilation and radial incision, to restore airway patency. Participants will be assessed for significant tracheal stenosis and will undergo treatment to determine the best approach for long-term symptom relief. The trial aims to provide insights into a novel technique that may improve outcomes for patients suffering from this condition.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 who have significant tracheal stenosis and are referred for endoscopic management.

Not a fit: Patients with known or suspected malignant airway stenosis or those with severe respiratory conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a more effective and lasting solution for patients with benign airway stenosis.

How similar studies have performed: While the use of cryotherapy is a novel approach in this context, other studies have shown promise with similar endoscopic techniques for airway management.

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

Where this trial is running

Jackson, Mississippi and 2 other locations

• University of Mississippi Medical Center — Jackson, Mississippi, United States (Recruiting)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
• Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)

Study contacts

• Principal investigator: Fabien Maldonado, MD — Vanderbilt University Medical Center
• Study coordinator: Ankush Ratwani, MD

Conditions Pulmonary Disease