Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion
NCT ID: NCT02150044
Last Updated: 2024-07-12
Study Results
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View full resultsBasic Information
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COMPLETED
NA
29 participants
INTERVENTIONAL
2010-02-28
2010-11-30
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
Acclarent Tympanostomy Tube Delivery System (TTDS).
tympanostomy tube delivery system
Interventions
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Acclarent Tympanostomy Tube Delivery System (TTDS).
tympanostomy tube delivery system
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Markedly atrophic, mono- or 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 sufficient visualization of and access to the tympanic membrane
* Anatomy that necessitates tympanostomy tube placement in the posterior half of the tympanic membrane
ALL
No
Sponsors
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Acclarent
INDUSTRY
Integra LifeSciences Corporation
INDUSTRY
Responsible Party
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Locations
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Kirkland, Washington, United States
Countries
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Other Identifiers
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CPR005008
Identifier Type: -
Identifier Source: org_study_id
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