Adjuvant Steroid Outcomes in Idiopathic Subglottic Stenosis
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Diagnosis of iSGS following the NoAAC criteria which involves ruling out known causes for airway stenosis. Participants may be newly diagnosed or carry an existing diagnosis of iSGS;
• Age Range: 18 years to 80 years old at the time of consent;
• Sex distribution: all eligible men and women will be included, and no one will be excluded;
• Have a life expectancy of ≥6 months; and,
• ECOG performance status of 0 or 1.
Locations
United States
California
University of California - San Diego
NOT_YET_RECRUITING
San Diego
University of California - San Francisco
NOT_YET_RECRUITING
San Francisco
Colorado
University of Colorado
NOT_YET_RECRUITING
Aurora
Florida
University of South Florida
RECRUITING
Tampa
Iowa
University of Iowa Hospitals and Clinics
NOT_YET_RECRUITING
Iowa City
Maryland
Johns Hopkins Hospital
RECRUITING
Baltimore
New York
University of Rochester Medical Center
NOT_YET_RECRUITING
Rochester
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Utah
University of Utah
RECRUITING
Salt Lake City
Wisconsin
University of Wisconsin - Madison
NOT_YET_RECRUITING
Madison
Contact Information
Primary
Alexander Hillel, M.D.
ahillel@jh.edu
4432876006
Time Frame
Start Date: 2026-05-20
Estimated Completion Date: 2032-01
Participants
Target number of participants: 226
Treatments
Experimental: Intralesional steroid injection with Triamcinolone
Placebo_comparator: Intralesional Placebo injection
Related Therapeutic Areas
Sponsors
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Leads: Johns Hopkins University