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

Conditions

• Stenosis of Trachea

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Spray cryo therapy — PROCEDURE
  normal flow, 5 seconds repeated for 3-5 cycles
• Standard of Care (SOC) — PROCEDURE
  1. Steroid injection 2. Radial mucosal incision 3. Balloon dilation (to normal airway diameter)

Study Details

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.

Key Dates

Start date

Jun 2, 2025

Status verified

Jul 2025

Primary completion

Jan 15, 2027

Completion

Jan 15, 2027

Study Design

Enrollment

50 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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)

Primary Outcome Measure

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

Central Contacts

• Christine Conley
  617-632-8386
  [email protected]

Locations (1)

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