Tracheal Stenosis Clinical Trial
Official title:
A Randomized Study of Mitomycin-C Application in the Endoscopic Surgical Treatment of Patients With Laryngotracheal Stenosis
Verified date | April 2019 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a randomized, prospective, double-blind, placebo-controlled clinical trial of the use of mitomycin-C topical application as an adjunctive treatment in the endoscopic surgical treatment of patients with laryngotracheal stenosis. We hypothesize that the use of mitomycin-C improves patient outcome in the endoscopic surgical treatment of laryngotracheal stenosis.
Status | Terminated |
Enrollment | 15 |
Est. completion date | February 2018 |
Est. primary completion date | February 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients with laryngotracheal stenosis, including subglottic stenosis or tracheal stenosis - Patients with disease amenable to treatment with endoscopic CO2 laser radial incisions and balloon dilation - Age greater than or equal to 18 years Exclusion Criteria: - Age less than 18 years - Pregnancy - Patients with glottic and supraglottic stenosis - Patients with disease not amenable to treatment with endoscopic CO2 laser radial incisions and balloon dilation - Patients with cartilaginous subglottic or tracheal stenosis |
Country | Name | City | State |
---|---|---|---|
United States | UCSF - Voice and Swallowing Clinic | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to Repeat Surgery | Length of time between surgeries for laryngotracheal stenosis during the study | 24 months | |
Secondary | Duration of Symptom Improvement | Symptom improvement was measured using the Clinical COPD Questionnaire, a 10-point patient reported symptom score. Duration of symptom improvement was defined as the time from surgery to the time that symptoms to worsened beyond a CCQ score of 1 or the time to the subsequent surgery if CCQ never exceeded 1 | 24 months | |
Secondary | Peak Inspiratory Flow Measurement | Change in maximum inspiratory air flow from preoperative value to highest postoperative value within 3 months of surgery. Calculation details: Highest postoperative value within 3 months of surgery minus preoperative value. | 3 months |
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