Treatment Alternatives in iSGS (NoAAC PR-02 Study)

Completed

Conditions studied: Idiopathic Subglottic Stenosis (iSGS)

In brief

The study is aimed at answering the questions; (1) How well do the most commonly used treatments in iSGS work? and (2) What quality-of-life trade-offs are associated with each approach? With the results of this trial, the investigators hope to provide information to iSGS patients: (1) Given my personal characteristics, conditions, and preferences, what should I expect will happen to me? and (2) What are my options, and what are the potential benefits and harms of these options?

Key facts

Study ID

NCT02481817

Run by

Vanderbilt University Medical Center

People needed

1239

Starts

2015-08-28

Expected to finish

2020-09-10

Last updated by the study team

2021-10-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Greater than 18 years of age.
• The lesion must involve the subglottis.

You may not qualify if…

• Less than 18 years of age
• Patients without capacity to consent for themselves
• History of significant laryngotracheal traumatic injury.
• History of endotracheal intubation or tracheotomy within 2 years of presentation.
• Major anterior neck surgery.
• History of neck irradiation.
• History of caustic or thermal injuries to the laryngotracheal complex.
• History of a clinically diagnosed vasculitis or collage vascular disease.
• Positive antinuclear cytoplasmic antibody titers.

Where it is running

• The University of Alabama at Birmingham — Birmingham, Alabama, United States
• Mayo Clinic — Scottsdale, Arizona, United States
• University of California Irvine — Irvine, California, United States
• Loma Linda University Health Care — Loma Linda, California, United States
• University of Southern California — Los Angeles, California, United States
• University of California Los Angeles — Los Angeles, California, United States
• Stanford University — Palo Alto, California, United States
• University of California San Diego — San Diego, California, United States
• University of California San Francisco — San Francisco, California, United States
• University of Colorado — Denver, Colorado, United States
• University of Miami — Miami, Florida, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Augusta University — Augusta, Georgia, United States
• Bastian Voice Institute — Downers Grove, Illinois, United States
• University of Iowa — Iowa City, Iowa, United States
• Louisiana State University — Baton Rouge, Louisiana, United States
• Johns Hopkins — Baltimore, Maryland, United States
• Harvard Medical School -Massachusetts Eye and Ear Infirmary — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• University of Nebraska — Omaha, Nebraska, United States
• New York University Medical Center — New York, New York, United States
• University of Rochester — Rochester, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Duke University — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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