CompletedNot Applicable

Treatment Alternatives in iSGS (NoAAC PR-02 Study)

United States1,239 participantsStarted 2015-08-28

Plain-language summary

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?

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Greater than 18 years of age. * The lesion must involve the subglottis. Exclusion Criteria: * 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.

What they're measuring

Treatment Effectiveness: Time to recurrent procedure

Timeframe: 3 years

Treatment Effectiveness: Need for tracheostomy

Timeframe: 3 years

Trial details

NCT IDNCT02481817

SponsorVanderbilt University Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-09-10

View on ClinicalTrials.gov More Idiopathic Subglottic Stenosis (iSGS) trials