Use of Steroid Injections to Prevent the Recurrence of Tracheal Stenosis in Idiopathic Subglottic… (NCT07228104) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Use of Steroid Injections to Prevent the Recurrence of Tracheal Stenosis in Idiopathic Subglottic Stenosis
United States226 participantsStarted 2026-05-01
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 endotracheal intubation or tracheostomy (intervention greater than 7 days immediately prior to diagnosis of subglottic stenosis);
* External physical trauma (including but not limited to blunt, penetration, chemical, or thermal injury) that causes injury to the subglottis;
* Clinical diagnosis of granulomatosis with polyangiitis (GPA);
* Radiation exposure to the neck;
* Current or previous treatment with Serial Intralesional Steroid Injection (SILSI);
* Use of systemic corticosteroids (oral, intravenous, or intramuscular glucocorticoids), regardless of indication, within 7 days before triamcinolone administration;
* Local administration of corticosteroids (ophthalmic, intranasal, inhaled) is not prohibited. However, the administration of intraarticular corticosteroids during the treatment phase is not recommended due to potential increased risk of infection.
* Intralesional administration, in a site other than the subglottis, of corticosteroids should be discussed with the site PI before enrollment
* Intraarticular corticosteroids during the treatment phase due to potential increased risk of infection;
* Use of anticoagulants other than aspirin (aspirin dose should not exceed 81mg);
* Pu…