Balloon Sinus Dilation In Office or OR



Status:Completed
Conditions:Sinusitis
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:18 - Any
Updated:10/25/2017
Start Date:April 1, 2008
End Date:July 1, 2010

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ESS Performed in Operating Room Versus Clinician's Office

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 balloon sinuplasty devices. Patients treated in the OR will have
endoscopic sinus surgery performed with or without balloon sinuplasty devices.

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 performed with the balloon sinuplasty devices. Patients treated in the OR will
have endoscopic sinus surgery performed with or without balloon sinuplasty devices. Both
primary treatment of sinusitis as well as revision of previously treated sinuses will be
allowed. Resource absorption will be evaluated for both venues.

Inclusion Criteria:

1. Age 18 years and greater

2. Both male and female patients eligible

3. 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)

4. Planned endoscopic sinus surgery (recommended by investigator, consented to by
patient)

Exclusion Criteria:

1. Cystic fibrosis

2. Samter's Triad (Aspirin sensitivity, Asthma, Sinonasal polyposis)

3. Sinonasal tumors or obstructive lesions

4. History of facial trauma that distorts sinus anatomy and precludes access to the sinus
ostium

5. Ciliary dysfunction

6. Pregnant females
We found this trial at
1
site
6701 Rockside Road
Independence, Ohio 44131
?
mi
from
Independence, OH
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