Cryospray Therapy for Benign Airway Stenosis

Phase 1

Recruiting

• Conditions: Stenosis Trachea
• Interventions: Device: Ballon dilation; Device: The truFreeze Spray Cryotherapy; Device: Radial Incision

• Registration Number: NCT06085209
• Lead Sponsor: Virginia Commonwealth University

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 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.

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 paucity of peer-reviewed data, and no randomized controlled trial has been performed. Thus, the study could potentially show that the use of spray cryo therapy could allow patients to undergo fewer procedures to treat this condition, or lengthen the amount of time required in between these procedures, or play a role in the resolution of this condition.

Study Timeline

• Study First Submitted: 2023-09-28
• Study Start: 2023-10-12
• Study First Submitted QC: 2023-10-12
• Study First Posted: 2023-10-16
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-19
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care	Ballon dilation	Bronchoscopic balloon dilation with radial cuts
Intervention	Radial Incision	Bronchoscopic balloon dilation with radial cuts \& truFreeze spray cryotherapy
Intervention	Ballon dilation	Bronchoscopic balloon dilation with radial cuts \& truFreeze spray cryotherapy
Intervention	The truFreeze Spray Cryotherapy	Bronchoscopic balloon dilation with radial cuts \& truFreeze spray cryotherapy
Standard of care	Radial Incision	Bronchoscopic balloon dilation with radial cuts

Primary Outcome Measures

Name	Time	Method
Degree of re-stenosis	6 months	The degree of re-stenosis at 6 months expressed as the percentage of airway lumen volume within the stenotic segment at 6 months compared to personal best patency volume on CT scan performed within five weeks of the study intervention.

Secondary Outcome Measures

Name	Time	Method
Change in Peak Expiratory Flow (PEF)	Continous for 6 months	Evidence supports the use of PEF as a simple, efficient, and accessible way of monitoring progression of tracheal stenosis. PEF has previously been captured in clinical encounters as component of the decision-making algorithm for surgical intervention in tracheal stenosis patients. Mobile Device Software 'App' can robustly capture longitudinal patient reported outcome measures. A previously developed mobile device software 'Airflo' for tracking patient-generated health data and has proven the ability to successfully implement this software.
Clinical Chronic Obstructive Pulmonary Disease Questionnaire (CCQ)	2 weeks before procedure, 2 weeks after the procedure, the 3 month study mark, the 6 months study mark,	The CCQ has been used as a validated quality of life measure in laryngotracheal stenosis. The investigators will send surveys out to patients at set time intervals to assess symptom improvement pre- and post-intervention. The questions are divided into three areas or domains. Symptoms 1, 2, 5, 6; Functional state 7, 8, 9, 10; Mental state 3 and 4. All items are equally weighted by adding score of ten items and dividing by the number ten. The score varies between 0 (very good health status) to 6 (extremely poor health status).
Incidence of complications between groups	Continous for 6 months	Incidence of complications (hypoxemia, bleeding, pneumothorax rate, barotrauma).

Trial Locations

Locations (1)

Virgnia Commonwealth University; 🇺🇸 Richmond, Virginia, United States