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

NCT04996173 | Active Not Recruiting FDA Device

• 1 other identifier: 211177
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Percent change in radiographic airway lumen volume at 6 months by CT

  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.

  2 weeks post-procedure to 6 months post-procedure.

Secondary Outcomes (2)

• Change in peak expiratory flow (PEF)

  Measurement intervals: 2 weeks pre-procedure, weekly post procedure until 6 months following

• Change in quality of life using the Clinical Chronic Obstructive Pulmonary Disease Questionnaire (COPD CCQ)

  Measurement intervals: 2 weeks pre-procedure, 2 weeks post procedure, 3 months and then 6 months post intervention.

Study Arms (2)

Control

PLACEBO COMPARATOR

Bronchoscopic Balloon Dilation with Radial Cuts

Device: Ballon Dilation; Device: Radial Incision

Intervention

ACTIVE COMPARATOR

Bronchoscopic Balloon Dilation with Radial Cuts \& truFreeze Spray Cryotherapy

Device: Spray cryotherapy; Device: Ballon Dilation; Device: Radial Incision

Interventions

Spray cryotherapy DEVICE

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.

Intervention

Ballon Dilation DEVICE

An endoscopic balloon that is inflated with water to pressures between 45 and 131 psi (3 to 9 atm) using a syringe and pressure manometer.

Control; Intervention

Radial Incision DEVICE

Carbon dioxide (CO2) laser or Monopolar electrocautery knife

Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Referral to interventional pulmonology or ENT for endoscopic management of suspected benign tracheal stenosis.
• Significant tracheal stenosis defined by stenosis ≥ 50% of tracheal lumen assessed on chest CT or symptomatology warranting evaluation.
• Able to provide informed consent
• Age \> 18

You may not qualify if:

• 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:
• Hypoxemia with need for supplemental oxygen ≥ 2L/min by nasal canula
• Recent pneumothorax in the previous 12 months
• Severe COPD (defined as a FEV1/FVC \< 70% and FEV1 \< 30% predicted) and/or severe persistent asthma.
• 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.
• Prior complications with SCT
• Contraindication to rigid bronchoscopy
• Significant tracheomalacia or alterations in cartilage integrity that would require stent placement or surgical referral as assessed by CT imaging.
• Greater then 1 BCAS intervention within 6 months before enrollment

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Virginia Commonwealth University: collaborator
• University of Mississippi Medical Center: collaborator

Study Sites (3)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

Location

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Fabien Maldonado, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pulmonary and Critical Care Fellow

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: August 9, 2021
• Study Start: October 25, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

US (3)