NCT04996173

Cryospray Therapy for Benign Airway Stenosis: a Randomized Pilot Study

Active, enrolled NA Last updated 26 March 2026

What this trial tests

NA trial testing Spray cryotherapy in Pulmonary Disease in 40 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

25 October 2021

Primary endpoint
31 December 2026

1 April 2027

Quick facts

Lead sponsor	Vanderbilt University Medical Center
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	40
Start date	25 October 2021
Primary completion	31 December 2026
Estimated completion	1 April 2027
Sites	3 locations across United States

Drugs / interventions tested

• Spray cryotherapy
• Ballon Dilation
• Radial Incision

Conditions studied

• Pulmonary Disease — all drugs for Pulmonary Disease →

Sponsor

Vanderbilt University Medical Center

Who can join

18 and older, any sex, with Pulmonary Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Percent change in radiographic airway lumen volume at 6 months by CT
  Time frame: 2 weeks post-procedure to 6 months post-procedure.
  The degree of re-stenosis expressed as the percentage of airway lumen volume within the stenotic segment, compared to personal best patency volume on CT scan post procedure.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Liquid nitrogen spray cryotherapy (SCT) in central airway disease: a multicenter prospective registry.
   Browning RF, Sachdeva AW, Parrish SC, Litle VR, et al · · 2025 · PMID 41522166 · DOI 10.21037/jtd-2025-1634
2. Inter-rater reliability of a novel objective endpoint for benign central airway stenosis interventions: Segmentation-based volume rendering of computed tomography scans.
   Ratwani AP, Chen H, Brown L, Schwartz EA, et al · · 2023 · PMID 37878622 · DOI 10.1371/journal.pone.0290393