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RECRUITING
NCT06761170
PHASE2

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

Sponsor: Beth Israel Deaconess Medical Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-06-02

Completion Date

2027-01-15

Last Updated

2025-07-28

Healthy Volunteers

No

Interventions

PROCEDURE

Spray cryo therapy

normal flow, 5 seconds repeated for 3-5 cycles

PROCEDURE

Standard of Care (SOC)

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

Locations (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States