Use of Steroid Injections to Prevent the Recurrence of Tracheal Stenosis in Idiopathic Subglottic Stenosis
Recruiting
Phase 3
Interventional Study
Idiopathic Subglottic Stenosis
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 226 (estimated)
- Sponsor
- Johns Hopkins University · Other
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About This Trial
This study will examine the ability of steroid injections into the site of stenosis following surgical dilation to delay the need for repeated surgical dilations.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Have a life expectancy of ≥6 months; and,
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.
Exclusion Criteria:
* History of subglottic stenosis from identifiable cause (not idiopathic), including any of the below clinical criteria:
* Prolonged endotra…
Contacts