NCT00939393

Balloon Sinus Dilation In Office or OR

ESS Performed in Operating Room Versus Clinician's Office

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Integra LifeSciences Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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 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.

Conditions

• Chronic Sinusitis

Interventions

Type	Name	Description
DEVICE	FESS instruments with or without balloon treatment	Intervention with metal instruments with or without balloon treatment
DEVICE	Balloon Sinuplasty	Balloon dilatation of sinuses

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-06-01
• Completion: 2010-07-01
• First posted: 2009-07-15
• Last updated: 2024-07-12
• Results posted: 2014-10-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study