Status:
COMPLETED
Balloon Sinus Dilation In Office or OR
Lead Sponsor:
Integra LifeSciences Corporation
Collaborating Sponsors:
Acclarent
Conditions:
Chronic Sinusitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Endoscopic sinus surgery will be performed either in the physician's office or in the operating room (OR). Patients treated in the physician's office will have endoscopic sinus surgery performed with ...
Detailed Description
In this study, endoscopic sinus surgery will be performed either in the physician's office or in the operating room (OR). Patients treated in the physician's office will have endoscopic sinus surgery ...
Eligibility Criteria
Inclusion
- Age 18 years and greater
- Both male and female patients eligible
- Diagnosis of chronic sinusitis that is not responsive to medical management (\> 12 weeks of symptoms and failed at least 3 to 6 weeks of appropriate antibiotic therapy as evidenced by presence of disease on CT scan)
- Planned endoscopic sinus surgery (recommended by investigator, consented to by patient)
Exclusion
- Cystic fibrosis
- Samter's Triad (Aspirin sensitivity, Asthma, Sinonasal polyposis)
- Sinonasal tumors or obstructive lesions
- History of facial trauma that distorts sinus anatomy and precludes access to the sinus ostium
- Ciliary dysfunction
- Pregnant females
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00939393
Start Date
April 1 2008
End Date
July 1 2010
Last Update
July 12 2024
Active Locations (1)
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1
Rockside Road Surgery Center
Independence, Ohio, United States, 44131