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

NCT06761170 | Recruiting Phase 2

• 1 other identifier: 2024P000875
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 2.To evaluate patient experience, physiological, anatomical changes, health care utilization and safety of the SCT plus balloon dilatation versus standard of care alone.

Conditions

Stenosis of Trachea

Keywords

Stenosis of trachea; benign; spray cryotherapy

Outcome Measures

Primary Outcomes (1)

• Need of re intervention

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

  Need of re intervention in two years

Secondary Outcomes (1)

• Time to re intervention

  Two years

Study Arms (2)

Interventional

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

1. Steroid injection 2. Radial mucosal incision 3. Balloon dilation (to normal airway diameter)

Procedure: Standard of Care (SOC)

Interventions

Spray cryo therapy PROCEDURE

normal flow, 5 seconds repeated for 3-5 cycles

Interventional

Standard of Care (SOC) PROCEDURE

1. Steroid injection 2. Radial mucosal incision 3. Balloon dilation (to normal airway diameter)

Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• American Association of Broncology and Interventional Pulmonology: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Related Publications (1)

• Leong P, Bardin PG, Lau KK. What's in a name? Expiratory tracheal narrowing in adults explained. Clin Radiol. 2013 Dec;68(12):1268-75. doi: 10.1016/j.crad.2013.06.017. Epub 2013 Aug 13.

  PMID: 23953005 BACKGROUND

MeSH Terms

Conditions

Tracheal Stenosis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Tracheal Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Christine Conley

CONTACT

617-632-8386; Cconley@bidmc.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Section of Interventional Pulmonology, Division of Thoracic Surgery and Interventional Pulmonology, Beth Israel Deaconess Medical Center, Professor of Medicine, Harvard Medical School,

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 7, 2025
• Study Start: June 2, 2025
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): January 15, 2027
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)