Recruiting
Phase 2

Cryotherapy vs. SoC

Sponsor:

Beth Israel Deaconess Medical Center

Code:

NCT06761170

Conditions

Stenosis of Trachea

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Spray cryo therapy

Standard of Care (SOC)

Study Details

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. 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.

Conditions

Stenosis of Trachea

Study ID

NCT06761170

Start date

Jun 2, 2025

Status verified date

Jul, 2025

Completion date

Jan 15, 2027

Anticipated

Primary completion date

Jan 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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)

active comparator: Control

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

Interventions

Spray cryo therapy

normal flow, 5 seconds repeated for 3-5 cycles

Standard of Care (SOC)

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

Primary outcome measure

  • Need of re intervention [ Time Frame: Need of re intervention in two years ]

Central Contacts and Locations

Central contacts

Christine Conley

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

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Adnan Majid, MD

617-632-8252amajid@bidmc.harvard.edu

Christine Conley, Healthcare Administration

6176328386cconley@bidmc.harvard.edu

More Information

Sponsor

Beth Israel Deaconess Medical Center

Last update posted

Jul 28, 2025

Last verified

Jul, 2025

Keywords

  • Stenosis of trachea
  • benign
  • spray cryotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center on 2025-07-28.