Global Sinus Surgery Registry
OASIS
OASIS Global Sinus Surgery Registry
1 other identifier
observational
252
1 country
25
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2015
Shorter than P25 for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 19, 2015
CompletedFirst Posted
Study publicly available on registry
January 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedResults Posted
Study results publicly available
February 27, 2019
CompletedJuly 12, 2024
July 1, 2024
10 months
January 19, 2015
June 9, 2017
July 10, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants Completing Follow-Up Visits
2 years
Eligibility Criteria
Adults diagnosed by an ENT surgeon with chronic rhinosinusitis (CRS) or recurrent acute rhinosinusitis (RARS) undergoing a primary transnasal endoscopic sinus surgery.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Integra LifeSciences Corporationlead
- Acclarentcollaborator
Study Sites (25)
Unknown Facility
Phoenix, Arizona, 85032, United States
Unknown Facility
Los Angeles, California, 90048, United States
Unknown Facility
Sacramento, California, 95815, United States
Unknown Facility
San Francisco, California, 94108, United States
Unknown Facility
Miami, Florida, 33136, United States
Unknown Facility
Atlanta, Georgia, 30342, United States
Unknown Facility
Evans, Georgia, 30809, United States
Unknown Facility
Berwyn, Illinois, 60402, United States
Unknown Facility
Chicago, Illinois, 60602, United States
Unknown Facility
Fort Wayne, Indiana, 46825, United States
Unknown Facility
West Burlington, Iowa, 52655, United States
Unknown Facility
Alexandria, Louisiana, 71303, United States
Unknown Facility
Bethesda, Maryland, 20889, United States
Unknown Facility
City of Saint Peters, Missouri, 63376, United States
Unknown Facility
Helena, Montana, 59601, United States
Unknown Facility
Henderson, Nevada, 89052, United States
Unknown Facility
Albuquerque, New Mexico, 87109, United States
Unknown Facility
Long Beach, New York, 11561, United States
Unknown Facility
New York, New York, 10021, United States
Unknown Facility
Knoxville, Tennessee, 37934, United States
Unknown Facility
Nashville, Tennessee, 37232, United States
Unknown Facility
Fort Worth, Texas, 76104, United States
Unknown Facility
Houston, Texas, 77098, United States
Unknown Facility
McKinney, Texas, 75070, United States
Unknown Facility
San Antonio, Texas, 78249, United States
Limitations and Caveats
Due to the early cancellation of the study, study results reported are limited to subject enrollment, subject demographics, and Adverse Events (SAE and Non-serious).
Results Point of Contact
- Title
- Patricia Chen
- Organization
- Acclarent, Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2015
First Posted
January 28, 2015
Study Start
January 1, 2015
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
July 12, 2024
Results First Posted
February 27, 2019
Record last verified: 2024-07