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RecruitingPhase 1NCT06085209

Cryospray Therapy for Benign Airway Stenosis

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

Sponsor

Virginia Commonwealth University

Enrollment

12 participants

Start Date

Oct 12, 2023

Study Type

INTERVENTIONAL

Conditions

Stenosis Trachea

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 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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria17

  • 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.

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Interventions

DEVICEThe truFreeze Spray Cryotherapy

A novel FDA cleared technique that allows for liquid nitrogen (LN2) to be delivered in a metered fashion via a catheter through a flexible bronchoscope.

DEVICEBallon dilation

An endoscopic balloon that is inflated with water to pressures between 45 and 131 psi (3-9 atm) using a syringe and pressure manometer.

DEVICERadial Incision

Carbon dioxide (CO2) laser or Monopolar electrocautery knife

Locations(1)

Virgnia Commonwealth University

Richmond, Virginia, United States

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NCT06085209