Trial from ClinicalTrials.gov

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Trial ID
NCT02481817
Ethics application status
Date submitted
22/06/2015
Date registered
22/06/2015
Date last updated
13/09/2017

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
Respiratory 0 0 0 0
Other respiratory disorders / diseases

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 - Patient quality of life assessment: voice (VHI-10)
Timepoint [1] 0 0
3 years
Secondary outcome [2] 0 0
QOL - Patient quality of life assessment: dysphagia (EAT-10)
Timepoint [2] 0 0
3 years
Secondary outcome [3] 0 0
QOL - Patient quality of life assessment: breathing (COPD dyspnea)
Timepoint [3] 0 0
3 years
Secondary outcome [4] 0 0
QOL - Patient quality of life assessment: general quality of life (SF-12)
Timepoint [4] 0 0
3 years
Secondary outcome [5] 0 0
Patient Reported Outcome - Non-traditional PRO focused on social support
Timepoint [5] 0 0
3 years
Secondary outcome [6] 0 0
Patient Reported Outcome - Non-traditional PRO focused on fear of disease recurrence
Timepoint [6] 0 0
3 years
Secondary outcome [7] 0 0
Patient Reported Outcome - Non-traditional PRO focused on disease anxiety and burden
Timepoint [7] 0 0
3 years
Secondary outcome [8] 0 0
Patient Reported Outcome - Non-traditional PRO focused on participatory decision-making style
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
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Current
Final
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
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United States of America
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Alabama
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United States of America
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Arizona
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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Iowa
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United States of America
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Louisiana
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United States of America
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Maryland
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Massachusetts
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United States of America
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Michigan
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Minnesota
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Nebraska
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New York
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United States of America
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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Tennessee
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Texas
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Utah
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United States of America
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Virginia
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United States of America
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Washington
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United States of America
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Wisconsin
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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
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Other collaborator category [8] 0 0
Other
Name [8] 0 0
Oregon Health and Science University
Address [8] 0 0
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Other
Name [9] 0 0
University of Washington
Address [9] 0 0
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Other
Name [10] 0 0
University of California, San Francisco
Address [10] 0 0
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Other
Name [11] 0 0
University of California, Los Angeles
Address [11] 0 0
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Other
Name [12] 0 0
University of California, San Diego
Address [12] 0 0
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Other
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University of Colorado, Denver
Address [13] 0 0
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Other
Name [14] 0 0
Baylor College of Medicine
Address [14] 0 0
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Other collaborator category [15] 0 0
Other
Name [15] 0 0
Louisiana State University Health Sciences Center in New Orleans
Address [15] 0 0
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Other
Name [16] 0 0
Charing Cross Hospital
Address [16] 0 0
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Other
Name [17] 0 0
University of Alabama at Birmingham
Address [17] 0 0
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Other
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University of Wisconsin, Madison
Address [18] 0 0
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Other
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University of Michigan
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Other
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University of Nebraska
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Other
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University of Iowa
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Other
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University of Texas
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Other
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Duke University
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Other
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University of North Carolina
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Other
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Augusta University
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Other
Name [26] 0 0
University of Sydney
Address [26] 0 0
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Other collaborator category [27] 0 0
Other
Name [27] 0 0
North American Airway Collaborative
Address [27] 0 0
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Other
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University of California, Irvine
Address [28] 0 0
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Other
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University of Pittsburgh
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Loma Linda University
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Stanford University
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University of Cincinnati
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Emory University
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Ohio State University
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University of Southern California
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Temple University
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Other
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Medical College of Wisconsin
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Other
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Landspitali University Hospital
Address [38] 0 0
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Other
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Bastian Voice Institute
Address [39] 0 0
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Other
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New York University School of Medicine
Address [40] 0 0
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Other
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Mayo Clinic
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Other
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University of Miami
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Other
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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
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
Cheryl Kinnard, RN
Address 0 0
Country 0 0
Phone 0 0
615-322-0333
Fax 0 0
Email 0 0
cheryl.kinnard@Vanderbilt.Edu
Contact person for scientific queries
Contact person responsible for updating information