Safety and Performance of the Steroid-Releasing S8 Sinus Implant
NCT ID: NCT01894503
Last Updated: 2018-07-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
5 participants
INTERVENTIONAL
2013-06-30
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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S8 Sinus Implant
Bilateral in-office placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
S8 Sinus Implant (mometasone furoate, 1350 mcg)
Bioabsorbable sinus implant with 1350 mcg of mometasone furoate released over 90 days
Interventions
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S8 Sinus Implant (mometasone furoate, 1350 mcg)
Bioabsorbable sinus implant with 1350 mcg of mometasone furoate released over 90 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of chronic sinusitis
* Prior bilateral total ethmoidectomy
* Recurrent sinus obstruction due to polyps grade 2 or higher
Exclusion Criteria
* Significant scarring or adhesions of the sinus
18 Years
ALL
No
Sponsors
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Intersect ENT
INDUSTRY
Responsible Party
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Principal Investigators
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Randall Ow, MD
Role: PRINCIPAL_INVESTIGATOR
Sacramento ENT
Locations
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Sacramento ENT
Sacramento, California, United States
Countries
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Other Identifiers
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P500-0513
Identifier Type: -
Identifier Source: org_study_id
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