Freezing spray may prevent airway scarring from returning
NCT ID NCT06085209
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This pilot study tests whether adding a liquid nitrogen cryospray to standard treatments (balloon dilation or laser incision) can prevent benign airway stenosis from coming back within 6 months. About 12 adults with significant tracheal narrowing will receive the cryospray during a bronchoscopy. The main goal is to see if the airway stays more open on CT scans compared to personal best.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- liquid nitrogen cryospray (truFreeze device)
- What this could lead to
- If it works, this could point toward a better way to prevent airway narrowing from coming back after treatment, reducing the need for repeat procedures.
- What could go wrong
- This is a very early pilot study with only 12 people, so results may not apply broadly. The added cryospray could cause side effects like tissue damage or infection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2023
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Virgnia Commonwealth University
RECRUITINGRichmond, Virginia, 23298, United States