Study Results
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View full resultsBasic Information
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TERMINATED
NA
14 participants
INTERVENTIONAL
2007-04-01
2007-11-01
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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Ethmoid Sinus Spacer placement
Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40
Ethmoid Sinus Spacer
Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40
Interventions
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Ethmoid Sinus Spacer
Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Both male and female
3. Ethmoid disease on CT scan
4. At least one non-ethmoid sinus requiring treatment
5. Failed medical management and symptomatic
Exclusion Criteria
2. Not sufficient room for placement of Spacer
3. Patient requires septoplasty
4. Has received steroid treatment with in 2 weeks
5. Extensive sinonasal osteoneogenesis preventing device placement
6. Sinonasal tumors or obstructive lesions
7. History of facial trauma that distorts sinus anatomy
8. Asthmatic patients with aspirin sensitivity
9. Pregnant or lactating females
21 Years
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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Fred Kuhn, MD
Role: PRINCIPAL_INVESTIGATOR
Georgia Nasal and Sinus Institute
Locations
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Georgia Nasal and Sinus Institute
Savannah, Georgia, United States
Countries
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Other Identifiers
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CPR02082
Identifier Type: -
Identifier Source: org_study_id
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