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Freezing spray could help patients breathe easier without repeat surgeries

NCT ID NCT04996173

Disease control Sponsor: Vanderbilt University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding a freezing spray (cryospray) to usual treatments can keep narrowed airways open longer in people with benign airway stenosis. About 40 adults will be randomly assigned to get either standard care alone or standard care plus cryospray. The goal is to see if the cryospray reduces scar tissue and delays the need for repeat procedures.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2021

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Referral to interventional pulmonology or ENT for endoscopic management of suspected benign tracheal stenosis. 2. Significant tracheal stenosis defined by stenosis ≥ 50% of tracheal lumen assessed on chest CT or symptomatology warranting evaluation. 3. Able to provide informed consent 4. Age \> 18 Exclusion Criteria: 1. Inability to provide informed consent. 2. Pregnancy 3. Known or suspected malignant central airway stenosis 4. Patient has already been enrolled in this study. 5. 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. Recent 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. Prior complications with SCT 6. Contraindication to rigid bronchoscopy 7. Significant tracheomalacia or alterations in cartilage integrity that would require stent placement or surgical referral as assessed by CT imaging. 8. Greater then 1 BCAS intervention within 6 months before enrollment

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Conditions

The condition(s) this trial relates to.

lung disorder tracheal stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulmonary disease

Contacts and locations

Locations

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Virginia Commonwealth University

    Richmond, Virginia, 23219, United States

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