Cryospray Therapy for Benign Airway Stenosis

NCT06085209 | Recruiting Phase 1 FDA Device

• 1 other identifier: HM20027230
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Stenosis Trachea

Keywords

cryospray therapy; benign airway stenosis

Outcome Measures

Primary Outcomes (1)

• Degree of re-stenosis

  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.

  6 months

Secondary Outcomes (3)

• Change in Peak Expiratory Flow (PEF)

  Continous for 6 months

• 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,

• Incidence of complications between groups

  Continous for 6 months

Study Arms (2)

Intervention

EXPERIMENTAL

Bronchoscopic balloon dilation with radial cuts \& truFreeze spray cryotherapy

Device: The truFreeze Spray Cryotherapy; Device: Ballon dilation; Device: Radial Incision

Standard of care

ACTIVE COMPARATOR

Bronchoscopic balloon dilation with radial cuts

Device: Ballon dilation; Device: Radial Incision

Interventions

The truFreeze Spray Cryotherapy DEVICE

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.

Intervention

Ballon dilation DEVICE

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

Intervention; Standard of care

Radial Incision DEVICE

Carbon dioxide (CO2) laser or Monopolar electrocautery knife

Intervention; Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• US Endoscopy Group Inc.: collaborator

Study Sites (1)

Virgnia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

MeSH Terms

Conditions

Tracheal Stenosis

Condition Hierarchy (Ancestors)

Tracheal Diseases; Respiratory Tract Diseases

Study Officials

• Ray Shepherd

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ramsha Hamid

CONTACT

(804) 628-2176; ramsha.hamid@vcuhealth.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded to the use of SCT to prevent knowledge of their group assignment from biasing their subjective assessments. Adjudicators in the primary outcome measurements (quantitative CT) will be blinded to group assignment as well.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly allocated in a 1:1 fashion to intervention standard of care (SOC) + SCT and control (SOC) groups. Participants will be blinded to the use of SCT to prevent knowledge of their group assignment from biasing their subjective assessments. Adjudicators in the primary outcome measurements (quantitative CT) will be blinded to group assignment as well.

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 16, 2023
• Study Start: October 12, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

US (1)