Treatment Alternatives in iSGS (NoAAC PR-02 Study)

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?

Conditions

• Idiopathic Subglottic Stenosis (iSGS)

Interventions

PROCEDURE

Endoscopic dilation of subglottic stenosis

This is accomplished with rigid instruments or inflatable balloons.

PROCEDURE

Endoscopic resection of the stenosis

This is accomplished with C02 lasers and paired with prolonged medical therapy after surgery.

PROCEDURE

Tracheal Resection

Resection of the affected tracheal segment with end-to-end anastomosis

Sponsors & Collaborators

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• The Cleveland Clinic

  collaborator OTHER

• University of Utah

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• Vanderbilt University

  collaborator OTHER

• University of Virginia

  collaborator OTHER

• Massachusetts Eye and Ear Infirmary

  collaborator OTHER

• Oregon Health and Science University

  collaborator OTHER

• University of Washington

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• University of California, Los Angeles

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• Baylor College of Medicine

  collaborator OTHER

• Louisiana State University Health Sciences Center in New Orleans

  collaborator OTHER

• Charing Cross Hospital

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• University of Wisconsin, Madison

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• University of Nebraska

  collaborator OTHER

• University of Iowa

  collaborator OTHER

• University of Texas

  collaborator OTHER

• Duke University

  collaborator OTHER

• University of North Carolina

  collaborator OTHER

• Augusta University

  collaborator OTHER

• University of Sydney

  collaborator OTHER

• North American Airway Collaborative

  collaborator UNKNOWN

• University of California, Irvine

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• Loma Linda University

  collaborator OTHER

• Stanford University

  collaborator OTHER

• University of Cincinnati

  collaborator OTHER

• Emory University

  collaborator OTHER

• Ohio State University

  collaborator OTHER

• University of Southern California

  collaborator OTHER

• Temple University

  collaborator OTHER

• Medical College of Wisconsin

  collaborator OTHER

• Landspitali University Hospital

  collaborator OTHER

• Bastian Voice Institute

  collaborator UNKNOWN

• NYU Langone Health

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• University of Miami

  collaborator OTHER

• University of Rochester

  collaborator OTHER

• Vanderbilt University Medical Center

  lead OTHER

Principal Investigators

• Alexander Gelbard, MD · Vanderbilt University Medical Center

• David O. Francis, MD, MS · Vanderbilt University Medical Center

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-08-28

Primary Completion

2020-09-10

Completion

2020-09-10

Countries

• United States
• Australia
• Iceland
• United Kingdom

Study Locations