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Global Sinus Surgery Registry (OASIS)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Acclarent
ClinicalTrials.gov Identifier:
NCT02347943
First received: January 19, 2015
Last updated: December 11, 2015
Last verified: December 2015
  Purpose
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
Chronic Rhinosinusitis Recurrent Acute Rhinosinusitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: OASIS Global Sinus Surgery Registry

Further study details as provided by Acclarent:

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

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


Enrollment: 269
Study Start Date: January 2015
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
  Eligibility

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.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02347943

  Show 25 Study Locations
Sponsors and Collaborators
Acclarent
  More Information

Responsible Party: Acclarent
ClinicalTrials.gov Identifier: NCT02347943     History of Changes
Other Study ID Numbers: CPR005044
Study First Received: January 19, 2015
Last Updated: December 11, 2015

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

ClinicalTrials.gov processed this record on June 22, 2017