Spray Cryotherapy for the Management of Benign Central Airway Stenosis (Cryo-BAS)
Recruiting
Phase 2
Interventional Study
Stenosis of Trachea
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 50 (estimated)
- Sponsor
- Beth Israel Deaconess Medical Center · Other
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About This Trial
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 airwa…
Trial Locations
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Eligibility Criteria
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 hemitho…
Contacts