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NCT Number: NCT06761170

Spray Cryotherapy for the Management of Benign Central Airway Stenosis (Cryo-BAS)

The goal of this clinical trial is to compare spray cryotherapy plus balloon dilatation versus current standard of Care (SoC - steroid injection, radial cuts and balloon dilatation) in patients with benign airway stenosis with simple stenosis. The main question[s] investigators aim to answer are:

1. What is the need for reintervention and time to reintervention in participants with benign airway stenosis with simple stenosis who receive spray cryotherapy plus balloon dilatation versus standard of care alone? 2. To evaluate patient experience, physiological, anatomical changes, health care utilization and safety of the SCT plus balloon dilatation versus standard of care alone.

Researchers will compare spray cryotherapy plus balloon dilatation versus current standard of Care (SoC - steroid injection, radial cuts and balloon dilatation) in patients with benign airway stenosis with simple stenosis to see if it reduces the need of re intervention.

Participants will surgery and receive one of the two interventions.

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Key information

Conditions

Stenosis of Trachea Respiratory Tract Diseases Tracheal Diseases Tracheal Stenosis

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

Investigators propose a single center, single-blinded (patient), randomized 1:1 trial comparing SCT plus Balloon dilatation (experimental group) vs SoC alone (control group). Investigators aim to recruit 50 patients.

Study will span 2-year duration with 1 year recruitment. Follow up at 6 weeks, 3 months, 6 months, 12 months. The patient's airway will be either a laryngeal mask airway or a rigid bronchoscopy for passive venting and gas egress.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Patients with symptomatic, benign, simple stenosis of the trachea and/or subglottic space.
  • 2. Stenotic airway of diameter < 1cm.

Exclusion criteria

  • Complex stenosis, cartilage involvement (malacia or fracture).
  • Patients with giant bullae (> a third of hemithorax) or bullae >3cm.
  • Concurrent tracheoesophageal fistula, active tracheal malignancy.
  • Presence of concomitant upper airway obstruction.
  • Pregnancy

Treatment and study plan

Spray cryo therapy

Procedure

normal flow, 5 seconds repeated for 3-5 cycles

Standard of care (SoC)

Procedure
  • Steroid injection
  • Radial mucosal incision
  • Balloon dilation (to normal airway diameter)

Primary outcomes

  1. Need of re intervention

    Time frame: Need of re intervention in two years

    Number of patients that require new intervention for the benign airway stenosis.

Secondary outcomes

  1. Time to re intervention

    Time frame: Two years

    Time it takes in days for a patient to need a re intervention for the benign airway stenosis after treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Christine Conley

CONTACT

[email protected]

617-632-8386

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • American Association of Broncology and Interventional Pulmonology

Registry information

Official study title

Spray Cryotherapy for the Management of Benign Central Airway Stenosis (Cryo-BAS): A Randomized Controlled Trial

Acronym: Cryo-BAS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 7, 2025
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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