Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
53 participants
INTERVENTIONAL
2010-09-30
2010-12-31
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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tympanostomy tube
performance and safety of tympanostomy tube delivery system
tympanostomy tube
tympanostomy tube delivery system
Interventions
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tympanostomy tube
tympanostomy tube delivery system
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Markedly atrophic, bimeric, severely retracted, atelectatic or perforated tympanic membrane
* Otitis externa
* Active acute otitis media
* Otitis media pathology requiring T-tubes
* Stenosed ear canal
* Anatomy that precludes visualization and access to tympanic membrane
* Anatomy that necessitates tympanostomy tube placement in posterior half of membrane
6 Months
ALL
No
Sponsors
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Acclarent
INDUSTRY
Integra LifeSciences Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Kenneth Faw, MD
Role: PRINCIPAL_INVESTIGATOR
Evergreen Sinus Center
Andrew Gould, MD
Role: PRINCIPAL_INVESTIGATOR
Advanced ENT and Allergy
Charles Syms, MD
Role: PRINCIPAL_INVESTIGATOR
Ear Medical Group
Jacob Zeiders, MD
Role: PRINCIPAL_INVESTIGATOR
South Coast ENT
Locations
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South Coast ENT
Port Saint Lucie, Florida, United States
Advanced ENT and Allergy
Louisville, Kentucky, United States
Ear Medical Group
San Antonio, Texas, United States
Evergreen Sinus Center
Kirkland, Washington, United States
Countries
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Other Identifiers
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CPR005013
Identifier Type: -
Identifier Source: org_study_id
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