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

July 24, 2025 updated by: Adnan Majid, MD, Beth Israel Deaconess Medical Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional

  1. Stenotic lumen diameter > 8mm:

    1. Spray Cryo Therapy for 5s, repeated 3-5 cycles
    2. Balloon dilation (to normal airway diameter)

  2. Stenotic lumen diameter < 8mm

    1. Balloon dilation (up to 8mm diameter)
    2. Spray Cryo Therapy for 5s, repeated 3-5 cycles 3) Balloon dilation (to normal airway diameter)
Procedure: Spray cryo therapy
normal flow, 5 seconds repeated for 3-5 cycles
Active Comparator: Control
  1. Steroid injection
  2. Radial mucosal incision
  3. Balloon dilation (to normal airway diameter)
Procedure: Standard of Care (SOC)
  1. Steroid injection
  2. Radial mucosal incision
  3. Balloon dilation (to normal airway diameter)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Need of re intervention in two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Collaborators

American Association of Broncology and Interventional Pulmonology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2025

Primary Completion (Estimated)

January 15, 2027

Study Completion (Estimated)

January 15, 2027

Study Registration Dates

First Submitted

December 23, 2024

First Submitted That Met QC Criteria

December 30, 2024

First Posted (Actual)

January 7, 2025

Study Record Updates

Last Update Posted (Actual)

July 28, 2025

Last Update Submitted That Met QC Criteria

July 24, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024P000875

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe