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

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

Interventions

DEVICE

Spray cryotherapy

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.

DEVICE

Ballon Dilation

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.

DEVICE

Radial Incision

Carbon dioxide (CO2) laser or Monopolar electrocautery knife

Sponsors & Collaborators

• Virginia Commonwealth University

  collaborator OTHER

• University of Mississippi Medical Center

  collaborator OTHER

• Vanderbilt University Medical Center

  lead OTHER

Principal Investigators

• Fabien Maldonado, MD · Vanderbilt University Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-10-25

Primary Completion

2026-12-31

Completion

2027-04-30

FDA Device

Yes

Countries

• United States

Study Locations