Cryospray Therapy Versus Standard of Care for Benign Airway Stenosis (CryoStasis)

ClinicalTrials.gov ID: NCT04996173

Public ClinicalTrials.gov record NCT04996173. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 3, 2026, 1:53 AM EDT

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Official title

Cryospray Therapy for Benign Airway Stenosis: a Randomized Pilot Study

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Benign central airway stenosis (BCAS) is an important cause of both pulmonary morbidity and mortality. Notable causes include post-intubation stenosis, collagen vascular diseases, airway trauma, infectious and idiopathic subglottic stenosis (iSGS). Surgery is the preferred definite option; however, the first therapeutic attempt is usually endoscopic to temporarily restore airway patency and symptomatic improvement. Several endoscopic modalities exist for treatment. Most commonly, thermal or laser therapy to make radial incisions into the stenotic lesion, followed by balloon dilation to increase the area of patency. Clinicians may also inject steroids or antineoplastic agents such as mitomycin C. All of these methods have benefits and associated risks. Symptomatic stenosis frequently reoccurs with these methods. For example, the investigators have been doing 3-4 ballon dilations procedures a week at our institution. Spray cryotherapy (SCT) is a novel FDA-cleared technique that allows for liquid nitrogen to be delivered through the working channel of a bronchoscope. Few retrospective studies exist without more robust clinical trial data to reduce the risk of bias and support its widespread use. The investigators postulate that SCT and standard of care techniques will improve airway patency volume at six months than the standard of care techniques alone. Some of the proposed advantages include improved wound healing which may translate to less scar tissue and thus improvements in airway patency for a longer duration of time.

Study identification

NCT ID: NCT04996173
Recruitment status: Active, not recruiting
Study type: Interventional
Phase: Not applicable
Lead sponsor: Vanderbilt University Medical Center; Other
Enrollment: 40 participants

Conditions and interventions

Conditions

Pulmonary Disease

Interventions

Device

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Oct 24, 2021
Primary completion: Dec 30, 2026
Completion: Mar 31, 2027
Last update posted: Mar 31, 2026

2021 – 2027

United States locations

U.S. sites: 3
U.S. states: 3
U.S. cities: 3

Facility	City	State	ZIP	Site status
University of Mississippi Medical Center	Jackson	Mississippi	39216	—
Vanderbilt University Medical Center	Nashville	Tennessee	37232	—
Virginia Commonwealth University	Richmond	Virginia	23219	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04996173, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Mar 31, 2026 · Synced Sep 3, 2026

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