Use of Steroid Injections to Prevent the Recurrence of Tracheal Stenosis in Idiopathic Subglottic Stenosis
NCT07228104 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 226
Last updated 2026-05-20
Summary
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.
Conditions
- Idiopathic Subglottic Stenosis
Interventions
- DRUG
-
Triamcinolone 0.1%
Intralesional Triamcinolone injection 3x at one, two, and three months following surgical dilation
- DRUG
-
Intralesional Placebo injection 3x at one, two, and three months following surgical dilation
Sponsors & Collaborators
-
National Heart, Lung, and Blood Institute (NHLBI)
collaborator NIH - lead OTHER
Principal Investigators
-
Alexander Hillel, MD · Johns Hopkins University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-01
- Primary Completion
- 2031-01-01
- Completion
- 2032-01-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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