Clinical Study of the Tympanostomy Tube Delivery System
NCT ID: NCT00939796
Last Updated: 2024-08-06
Study Results
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View full resultsBasic Information
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COMPLETED
NA
16 participants
INTERVENTIONAL
2009-03-31
2009-07-31
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 Delivery System (TTDS)
Tympanostomy tube placement with Acclarent tube delivery system
Acclarent Tympanostomy Tube Delivery System
A device which provides a means to create a myringotomy with insertion of a proloaded tympanostomy tube (TT) for placement of the TT in patients indicated for such treatment for Otitis Media
Interventions
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Acclarent Tympanostomy Tube Delivery System
A device which provides a means to create a myringotomy with insertion of a proloaded tympanostomy tube (TT) for placement of the TT in patients indicated for such treatment for Otitis Media
Eligibility Criteria
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Inclusion Criteria
2. Either male or female
Exclusion Criteria
2. Markedly atrophic, mono- or bimeric, severely retracted, atelectatic or perforated tympanic membrane
3. Otitis externa
4. Active acute otitis media
5. Otitis media pathology
6. Stenosed ear canal
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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Charles Syms, III, MD
Role: PRINCIPAL_INVESTIGATOR
Ear Medical Group
Charles Wilson, MD
Role: PRINCIPAL_INVESTIGATOR
Bay Area ENT
Locations
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Bay Area ENT
Biloxi, Mississippi, United States
Ear Medical Group
San Antonio, Texas, United States
Countries
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Other Identifiers
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CPR005005
Identifier Type: -
Identifier Source: org_study_id
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