Study Results
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View full resultsBasic Information
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COMPLETED
NA
25 participants
INTERVENTIONAL
2008-12-31
2011-06-30
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 placement
Tympanostomy Tube Delivery System (TTDS) used for placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).
Tympanostomy Tube Delivery System
Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)
Interventions
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Tympanostomy Tube Delivery System
Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with either Chronic Otitis Media with Effusion or recurrent Acute Otitis Media and scheduled to undergo bilateral or unilateral tympanostomy tube insertion.
3. Either male or female -
Exclusion Criteria
2. Markedly atrophic, retracted, atelectatic or perforated tympanic membrane.
3. Otitis externa
4. Active acute otitis media
5. Thickened Tympanic Membrane
6. Thick mucoid effusion (also known as "glue ear")
7. Otitis media pathology requiring T-tubes -
1 Year
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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Henry Tan, MD
Role: PRINCIPAL_INVESTIGATOR
KK Women's and Children's Hospital, Singapore
Locations
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KK Women's and Children's Hospital Singapore
Singapore, , Singapore
Countries
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Other Identifiers
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CPR005004
Identifier Type: -
Identifier Source: org_study_id
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