Global Sinus Surgery Registry

NCT ID: NCT02347943

Last Updated: 2024-07-12

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

252 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2015-11-01

Brief Summary

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This study evaluates long-term safety and effectiveness of primary sinus surgery in a real-world population of adults with chronic rhinosinusitis (CRS) or recurrent acute rhinosinusitis (RARS). This post-market study will evaluate sinus surgery performed using commercially available sinus instrumentation (e.g. sinus balloon catheters, powered microdebriders, manual instruments).

Detailed Description

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Conditions

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Chronic Rhinosinusitis Recurrent Acute Rhinosinusitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years or minimum adult age as required by local regulations
* The subject has a planned primary sinus surgery, which includes either traditional transnasal endoscopic sinus surgery (ESS), balloon sinus dilation (BSD) or a hybrid procedure
* Subjects diagnosed by ENT surgeon with chronic rhinosinusitis (CRS) or recurrent acute rhinosinusitis (RARS) per AAO-HNS or EPOS adult sinusitis clinical practice guidelines
* The subject has been informed of the nature of the registry and has consented to participate and authorized the collection and release of medical information by signing a consent form
* Subject is able to read and understand local language

Exclusion Criteria

* Prior sinus surgery. Septoplasty, Nasal Polypectomy, Septorhinoplasty, Nasal Valve and Turbinate Reduction surgeries are not exclusions
* Planned surgery of any of the following : orbital decompression, skull base, neoplasm, lacrimal, UPPP, aesthetic surgery, Potts Puffy tumor, Draf III
* Planned external approaches (i.e. not trans-nasal)
* Planned off-label usage of balloon sinus dilation products.
* Balloon sinus dilation performed with a non-Acclarent balloon product
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Acclarent

INDUSTRY

Sponsor Role collaborator

Integra LifeSciences Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Phoenix, Arizona, United States

Site Status

Los Angeles, California, United States

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Sacramento, California, United States

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San Francisco, California, United States

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Miami, Florida, United States

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Atlanta, Georgia, United States

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Evans, Georgia, United States

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Berwyn, Illinois, United States

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Chicago, Illinois, United States

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Fort Wayne, Indiana, United States

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West Burlington, Iowa, United States

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Alexandria, Louisiana, United States

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Bethesda, Maryland, United States

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City of Saint Peters, Missouri, United States

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Helena, Montana, United States

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Henderson, Nevada, United States

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Albuquerque, New Mexico, United States

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Long Beach, New York, United States

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New York, New York, United States

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Knoxville, Tennessee, United States

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Nashville, Tennessee, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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McKinney, Texas, United States

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San Antonio, Texas, United States

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Countries

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United States

Other Identifiers

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CPR005044

Identifier Type: -

Identifier Source: org_study_id

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