Cryospray therapy for treating benign airway stenosis

Cryospray Therapy for Benign Airway Stenosis: a Pilot Study (Pilot-CRYOSTASIS)

This study is testing if adding cryospray therapy to standard treatments can help people with benign airway stenosis avoid having their condition come back within six months.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Virginia Commonwealth University (other)
• Locations: 1 site (Richmond, Virginia)
• Trial ID: NCT06085209 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with significant tracheal stenosis of 50% or more, referred for endoscopic management.

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

Why it matters

Potential benefit: If successful, this therapy could reduce the frequency of procedures needed to manage benign airway stenosis.

How similar studies have performed: While cryospray therapy is used in clinical practice, this study is novel as it is the first randomized controlled trial evaluating its effectiveness.

Eligibility criteria

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 this trial is running

Richmond, Virginia

• Virgnia Commonwealth University — Richmond, Virginia, United States (RECRUITING)

Study contacts

• Principal investigator: Ray Shepherd — Virginia Commonwealth University
• Study coordinator: Ramsha Hamid

Conditions: Stenosis Trachea, cryospray therapy, benign airway stenosis