Phase 2: Spray cryo therapy for Stenosis of Trachea
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.
Official registry: https://clinicaltrials.gov/study/NCT06761170 · Beth Israel Deaconess Medical Center · enrollment listed as 50
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Spray cryo therapy, or Standard of Care (SOC). The registry lists allocation as randomized. 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.
They plan to enroll about 50 people at Boston. Taking part typically means a procedure as part of the study plus check-ins.
Official title (unrewritten)
Spray Cryotherapy for the Management of Benign Central Airway Stenosis (Cryo-BAS): A Randomized Controlled Trial
Interventions: Spray cryo therapy, Standard of Care (SOC)
Primary outcome (registry wording): Need of re intervention
Who it is for (from inclusion criteria)
- 1\. Patients with symptomatic, benign, simple stenosis of the trachea and/or subglottic space
- 2\. Stenotic airway of diameter \< 1cm
Who the registry excludes
- 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
Public study contact (from the registry)
Christine Conley
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- Beth Israel Deaconess Medical Center — Boston, Massachusetts (recruiting)
FAQ about this NCT record
Is NCT06761170 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06761170?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06761170?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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