Treatment Alternatives in Adult Rare Disease; Assessment of Options in Idiopathic Subglottic Stenosis North American Airway Collaborative PR-02 Study (NoAAC PR-02 Study)
Status: Completed
Location: See all (42) locations...
Intervention Type: Procedure
Study Type: Observational
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?
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Greater than 18 years of age.
• The lesion must involve the subglottis.
Locations
United States
Alabama
The University of Alabama at Birmingham
Birmingham
Arizona
Mayo Clinic
Scottsdale
California
University of California Irvine
Irvine
Loma Linda University Health Care
Loma Linda
University of California Los Angeles
Los Angeles
University of Southern California
Los Angeles
Stanford University
Palo Alto
University of California San Diego
San Diego
University of California San Francisco
San Francisco
Colorado
University of Colorado
Denver
Florida
University of Miami
Miami
Georgia
Emory University School of Medicine
Atlanta
Augusta University
Augusta
Iowa
University of Iowa
Iowa City
Illinois
Bastian Voice Institute
Downers Grove
Louisiana
Louisiana State University
Baton Rouge
Massachusetts
Harvard Medical School -Massachusetts Eye and Ear Infirmary
Boston
Maryland
Johns Hopkins
Baltimore
Michigan
University of Michigan
Ann Arbor
Minnesota
Mayo Clinic
Rochester
North Carolina
University of North Carolina
Chapel Hill
Duke University
Durham
Nebraska
University of Nebraska
Omaha
New York
New York University Medical Center
New York
University of Rochester
Rochester
Ohio
University of Cincinatti
Cincinnati
Cleveland Clinic
Cleveland
The Ohio State University Wexner Medical Center
Columbus
Oregon
Oregon Health & Science University
Portland
Pennsylvania
Temple University
Philadelphia
University of Pittsburgh
Pittsburgh
Tennessee
Vanderbilt University Medical Center
Nashville
Texas
University of Texas Southwestern
Dallas
Baylor College of Medicine
Houston
Utah
University of Utah
Salt Lake City
Virginia
University of Virginia
Charlottesville
Washington
University of Washington
Seattle
Wisconsin
University of Wisconsin
Madison
Medical College of Wisconsin
Milwaukee
Other Locations
Australia
University of Sydney
St Leonards
Iceland
Landspitali University Hospital
Reykjavik
United Kingdom
Charing Cross Hospital, Imperial College London
London
Time Frame
Start Date: 2015-08-28
Completion Date: 2020-09-10
Participants
Target number of participants: 1239
Treatments
iSGS patients
Participants will receive standard of care treatment at the respective center and will be followed longitudinally for symptom changes, need for further treatment, complications, and will have Patient-reported outcomes (PROs) administered at a priori determined intervals.
Authors
Kwang Sung, Dale C. Ekbom, Joshua S. Schindler, Joel Blumin, Rupali N. Shah, Julina Ongkasuwan, Ramon Franco, Robbi Kupfer, Andrew Sikora, Seth H. Dailey, Christopher Wootten, Seth Cohen, Dinesh Chhetri, Donald Donovan, Samir Makani, James Netterville, James J. Daniero, David Francis, Philip Weissbrod, David G. Lott, Richard K McHugh, Eric S. Edell, Alexander T. Hillel, Clark Rosen, Gregory Postma, Matthew S. Clary, Otis Rickman, Edward Damrose, Brianna K Crawley, Milan Amin, David E Rosow, Albert Merati, Paul C. Bryson, Michael S. Benninger, Glenn T Schneider, Paul F. Castellanos, Jan L. Kasperbauer, Laura Matrka, Andrew J. McWhorter, Lindsay Reder, Robert Buckmire, Mark Courey, Norman Hogikyan, Alexander Gelbard, Brent Richardson, Sunil Verma, Henry Hoffman, Christopher M. Bingcang, Craig Villari, David Veivers, Guri Sandhu
Related Therapeutic Areas
Sponsors
Collaborators: University of Southern California, University of Rochester, Stanford University, University of Miami, Medical College of Wisconsin, University of Texas, University of Michigan, University of Wisconsin, Madison, Oregon Health and Science University, Duke University, University of Washington, University of North Carolina, University of Iowa, University of Virginia, Johns Hopkins University, University of Utah, Bastian Voice Institute, Baylor College of Medicine, University of Colorado, Denver, University of Cincinnati, Ohio State University, North American Airway Collaborative, Mayo Clinic, Massachusetts Eye and Ear Infirmary, University of California, San Diego, University of Nebraska, Vanderbilt University, Emory University, Charing Cross Hospital, University of California, Irvine, The Cleveland Clinic, Loma Linda University, University of Pittsburgh, Louisiana State University Health Sciences Center in New Orleans, NYU Langone Health, Temple University, Landspitali University Hospital, University of Sydney, Augusta University, University of Alabama at Birmingham, University of California, San Francisco, University of California, Los Angeles, Patient-Centered Outcomes Research Institute
Leads: Vanderbilt University Medical Center