Safety and Efficacy of Balloon Sinuplasty in Pediatric Sinusitis
NCT ID: NCT00939471
Last Updated: 2024-07-12
Study Results
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View full resultsBasic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2007-04-01
2010-05-01
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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Relieva™ Balloon Sinuplasty™ System
Balloon Dilation of sinus ostium
Relieva™ Balloon Sinuplasty™ System
Balloon dilation will be performed using endoscopic equipment with video documentation capability.
Interventions
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Relieva™ Balloon Sinuplasty™ System
Balloon dilation will be performed using endoscopic equipment with video documentation capability.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Both male and female patients eligible
3. Planned surgical intervention (i.e. endoscopic sinus surgery, adenoidectomy, sinus irrigation for obtaining a culture) recommended by PI, consented to by patient's legal guardian)
4. Longstanding sinusitis: \>3 mo symptoms OR 6 episodes/yr AND failed 2 courses antibiotics followed by positive CT scan
Exclusion Criteria
2. Cystic fibrosis
3. Extensive sinonasal osteoneogenesis
4. Sinonasal tumors or obstructive lesions
5. History of facial trauma that distorts sinus anatomy and precludes access to the sinus ostium
6. Ciliary dysfunction
7. For female patients of childbearing age: the patient is either pregnant or lactating
2 Years
17 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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Hassan Ramadan, MD
Role: PRINCIPAL_INVESTIGATOR
West Virginia University
Locations
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West Virginia University
Morgantown, West Virginia, United States
Countries
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Other Identifiers
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CPR01918
Identifier Type: -
Identifier Source: org_study_id
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