Recruiting
Phase 1

SCT

Sponsor:

Virginia Commonwealth University

Code:

NCT06085209

Conditions

Stenosis Trachea

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

The truFreeze Spray Cryotherapy

Ballon dilation

Radial Incision

Study Details

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

Study ID

NCT06085209

Start date

Oct 12, 2023

Status verified date

Dec, 2025

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

12 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention

Bronchoscopic balloon dilation with radial cuts \& truFreeze spray cryotherapy

active comparator: Standard of care

Bronchoscopic balloon dilation with radial cuts

Interventions

The 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.

Ballon 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.

Radial Incision

Carbon dioxide (CO2) laser or Monopolar electrocautery knife

Primary outcome measure

  • Degree of re-stenosis [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

Virgnia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Contacts

More Information

Sponsor

Virginia Commonwealth University

Last update posted

Dec 10, 2025

Last verified

Dec, 2025

Keywords

  • cryospray therapy
  • benign airway stenosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Virginia Commonwealth University on 2025-12-10.