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Global Sinus Surgery Registry (OASIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02347943
Recruitment Status : Terminated
First Posted : January 28, 2015
Last Update Posted : December 15, 2015
Information provided by (Responsible Party):

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).

Condition or disease
Chronic Rhinosinusitis Recurrent Acute Rhinosinusitis

Study Type : Observational
Actual Enrollment : 269 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: OASIS Global Sinus Surgery Registry
Study Start Date : January 2015
Primary Completion Date : November 2015
Study Completion Date : November 2015

Primary Outcome Measures :
  1. Mean Intra-patient Change in SNOT-22 Score [ Time Frame: Baseline through 2 years ]

Other Outcome Measures:
  1. Mean Intra-patient Change in CSS Score [ Time Frame: Baseline through 2 years ]
  2. Mean Intra-patient Change in WPAI Score [ Time Frame: Baseline through 2 years ]
  3. Mean Intra-patient Change in EQ-5D-5L [ Time Frame: Baseline through 2 years ]
  4. Change in disease-specific medication usage [ Time Frame: 2 years ]
  5. Number of subjects requiring revision [ Time Frame: 2 years ]
  6. Change in number of sinus infections [ Time Frame: Baseline through 2 years ]
  7. Adverse Events [ Time Frame: 2 years ]
  8. Mean Number of Days to Return to Normal Activities [ Time Frame: 4 weeks ]
  9. Mean Subject-Reported Satisfaction with Sinus Surgery [ Time Frame: 2 years ]
    Subjects will report satisfaction of a scale of 1-10

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02347943

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Sponsors and Collaborators

Responsible Party: Acclarent Identifier: NCT02347943     History of Changes
Other Study ID Numbers: CPR005044
First Posted: January 28, 2015    Key Record Dates
Last Update Posted: December 15, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases