Global Sinus Surgery Registry (OASIS)

March 4, 2019 updated by: Acclarent

OASIS Global Sinus Surgery Registry

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).

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

252

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
    • California
      • Los Angeles, California, United States, 90048
      • Sacramento, California, United States, 95815
      • San Francisco, California, United States, 94108
    • Florida
      • Miami, Florida, United States, 33136
    • Georgia
      • Atlanta, Georgia, United States, 30342
      • Evans, Georgia, United States, 30809
    • Illinois
      • Berwyn, Illinois, United States, 60402
      • Chicago, Illinois, United States, 60602
    • Indiana
      • Fort Wayne, Indiana, United States, 46825
    • Iowa
      • West Burlington, Iowa, United States, 52655
    • Louisiana
      • Alexandria, Louisiana, United States, 71303
    • Maryland
      • Bethesda, Maryland, United States, 20889
    • Missouri
      • Saint Peters, Missouri, United States, 63376
    • Montana
      • Helena, Montana, United States, 59601
    • Nevada
      • Henderson, Nevada, United States, 89052
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
    • New York
      • Long Beach, New York, United States, 11561
      • New York, New York, United States, 10021
    • Tennessee
      • Knoxville, Tennessee, United States, 37934
      • Nashville, Tennessee, United States, 37232
    • Texas
      • Fort Worth, Texas, United States, 76104
      • Houston, Texas, United States, 77098
      • McKinney, Texas, United States, 75070
      • San Antonio, Texas, United States, 78249

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults diagnosed by an ENT surgeon with chronic rhinosinusitis (CRS) or recurrent acute rhinosinusitis (RARS) undergoing a primary transnasal endoscopic sinus surgery.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants Completing Follow-Up Visits
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acclarent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

January 19, 2015

First Submitted That Met QC Criteria

January 27, 2015

First Posted (Estimate)

January 28, 2015

Study Record Updates

Last Update Posted (Actual)

March 19, 2019

Last Update Submitted That Met QC Criteria

March 4, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPR005044

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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