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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02481817




Registration number
NCT02481817
Ethics application status
Date submitted
22/06/2015
Date registered
25/06/2015
Date last updated
28/10/2021

Titles & IDs
Public title
Treatment Alternatives in iSGS (NoAAC PR-02 Study)
Scientific title
Treatment Alternatives in Adult Rare Disease; Assessment of Options in Idiopathic Subglottic Stenosis North American Airway Collaborative PR-02 Study (NoAAC PR-02 Study)
Secondary ID [1] 0 0
150917
Universal Trial Number (UTN)
Trial acronym
NoAAC PR-02
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Subglottic Stenosis (iSGS) 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - Endoscopic dilation of subglottic stenosis
Treatment: Surgery - Endoscopic resection of the stenosis
Treatment: Surgery - Tracheal Resection

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.


Treatment: Surgery: Endoscopic dilation of subglottic stenosis
This is accomplished with rigid instruments or inflatable balloons.

Treatment: Surgery: Endoscopic resection of the stenosis
This is accomplished with C02 lasers and paired with prolonged medical therapy after surgery.

Treatment: Surgery: Tracheal Resection
Resection of the affected tracheal segment with end-to-end anastomosis
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Treatment Effectiveness: Time to recurrent procedure
Timepoint [1] 0 0
3 years
Primary outcome [2] 0 0
Treatment Effectiveness: Need for tracheostomy
Timepoint [2] 0 0
3 years
Secondary outcome [1] 0 0
QOL
Timepoint [1] 0 0
3 years
Secondary outcome [2] 0 0
QOL
Timepoint [2] 0 0
3 years
Secondary outcome [3] 0 0
QOL
Timepoint [3] 0 0
3 years
Secondary outcome [4] 0 0
QOL
Timepoint [4] 0 0
3 years
Secondary outcome [5] 0 0
Patient Reported Outcome
Timepoint [5] 0 0
3 years
Secondary outcome [6] 0 0
Patient Reported Outcome
Timepoint [6] 0 0
3 years
Secondary outcome [7] 0 0
Patient Reported Outcome
Timepoint [7] 0 0
3 years
Secondary outcome [8] 0 0
Patient Reported Outcome
Timepoint [8] 0 0
3 years

Eligibility
Key inclusion criteria
- Greater than 18 years of age.

- The lesion must involve the subglottis.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/08/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/09/2020
Sample size
Target
Accrual to date
Final
1239
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
University of Sydney - St Leonards
Recruitment postcode(s) [1] 0 0
- St Leonards
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Iowa
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Minnesota
Country [14] 0 0
United States of America
State/province [14] 0 0
Nebraska
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
North Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Ohio
Country [18] 0 0
United States of America
State/province [18] 0 0
Oregon
Country [19] 0 0
United States of America
State/province [19] 0 0
Pennsylvania
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Utah
Country [23] 0 0
United States of America
State/province [23] 0 0
Virginia
Country [24] 0 0
United States of America
State/province [24] 0 0
Washington
Country [25] 0 0
United States of America
State/province [25] 0 0
Wisconsin
Country [26] 0 0
Iceland
State/province [26] 0 0
Reykjavik
Country [27] 0 0
United Kingdom
State/province [27] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
Vanderbilt University Medical Center
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Patient-Centered Outcomes Research Institute
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
The Cleveland Clinic
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University of Utah
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Johns Hopkins University
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Vanderbilt University
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
University of Virginia
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Massachusetts Eye and Ear Infirmary
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Oregon Health and Science University
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
University of Washington
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
University of California, San Francisco
Address [10] 0 0
Country [10] 0 0
Other collaborator category [11] 0 0
Other
Name [11] 0 0
University of California, Los Angeles
Address [11] 0 0
Country [11] 0 0
Other collaborator category [12] 0 0
Other
Name [12] 0 0
University of California, San Diego
Address [12] 0 0
Country [12] 0 0
Other collaborator category [13] 0 0
Other
Name [13] 0 0
University of Colorado, Denver
Address [13] 0 0
Country [13] 0 0
Other collaborator category [14] 0 0
Other
Name [14] 0 0
Baylor College of Medicine
Address [14] 0 0
Country [14] 0 0
Other collaborator category [15] 0 0
Other
Name [15] 0 0
Louisiana State University Health Sciences Center in New Orleans
Address [15] 0 0
Country [15] 0 0
Other collaborator category [16] 0 0
Other
Name [16] 0 0
Charing Cross Hospital
Address [16] 0 0
Country [16] 0 0
Other collaborator category [17] 0 0
Other
Name [17] 0 0
University of Alabama at Birmingham
Address [17] 0 0
Country [17] 0 0
Other collaborator category [18] 0 0
Other
Name [18] 0 0
University of Wisconsin, Madison
Address [18] 0 0
Country [18] 0 0
Other collaborator category [19] 0 0
Other
Name [19] 0 0
University of Michigan
Address [19] 0 0
Country [19] 0 0
Other collaborator category [20] 0 0
Other
Name [20] 0 0
University of Nebraska
Address [20] 0 0
Country [20] 0 0
Other collaborator category [21] 0 0
Other
Name [21] 0 0
University of Iowa
Address [21] 0 0
Country [21] 0 0
Other collaborator category [22] 0 0
Other
Name [22] 0 0
University of Texas
Address [22] 0 0
Country [22] 0 0
Other collaborator category [23] 0 0
Other
Name [23] 0 0
Duke University
Address [23] 0 0
Country [23] 0 0
Other collaborator category [24] 0 0
Other
Name [24] 0 0
University of North Carolina
Address [24] 0 0
Country [24] 0 0
Other collaborator category [25] 0 0
Other
Name [25] 0 0
Augusta University
Address [25] 0 0
Country [25] 0 0
Other collaborator category [26] 0 0
Other
Name [26] 0 0
University of Sydney
Address [26] 0 0
Country [26] 0 0
Other collaborator category [27] 0 0
Other
Name [27] 0 0
North American Airway Collaborative
Address [27] 0 0
Country [27] 0 0
Other collaborator category [28] 0 0
Other
Name [28] 0 0
University of California, Irvine
Address [28] 0 0
Country [28] 0 0
Other collaborator category [29] 0 0
Other
Name [29] 0 0
University of Pittsburgh
Address [29] 0 0
Country [29] 0 0
Other collaborator category [30] 0 0
Other
Name [30] 0 0
Loma Linda University
Address [30] 0 0
Country [30] 0 0
Other collaborator category [31] 0 0
Other
Name [31] 0 0
Stanford University
Address [31] 0 0
Country [31] 0 0
Other collaborator category [32] 0 0
Other
Name [32] 0 0
University of Cincinnati
Address [32] 0 0
Country [32] 0 0
Other collaborator category [33] 0 0
Other
Name [33] 0 0
Emory University
Address [33] 0 0
Country [33] 0 0
Other collaborator category [34] 0 0
Other
Name [34] 0 0
Ohio State University
Address [34] 0 0
Country [34] 0 0
Other collaborator category [35] 0 0
Other
Name [35] 0 0
University of Southern California
Address [35] 0 0
Country [35] 0 0
Other collaborator category [36] 0 0
Other
Name [36] 0 0
Temple University
Address [36] 0 0
Country [36] 0 0
Other collaborator category [37] 0 0
Other
Name [37] 0 0
Medical College of Wisconsin
Address [37] 0 0
Country [37] 0 0
Other collaborator category [38] 0 0
Other
Name [38] 0 0
Landspitali University Hospital
Address [38] 0 0
Country [38] 0 0
Other collaborator category [39] 0 0
Other
Name [39] 0 0
Bastian Voice Institute
Address [39] 0 0
Country [39] 0 0
Other collaborator category [40] 0 0
Other
Name [40] 0 0
NYU Langone Health
Address [40] 0 0
Country [40] 0 0
Other collaborator category [41] 0 0
Other
Name [41] 0 0
Mayo Clinic
Address [41] 0 0
Country [41] 0 0
Other collaborator category [42] 0 0
Other
Name [42] 0 0
University of Miami
Address [42] 0 0
Country [42] 0 0
Other collaborator category [43] 0 0
Other
Name [43] 0 0
University of Rochester
Address [43] 0 0
Country [43] 0 0

Ethics approval
Ethics application status

Summary
Brief 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?
Trial website
https://clinicaltrials.gov/ct2/show/NCT02481817
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alexander Gelbard, MD
Address 0 0
Vanderbilt University Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02481817