NCT01525849

Randomized Evaluation of Maxillary Antrostomy Versus Ostial Dilation Efficacy Through Long-Term Follow-Up

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: Entellus Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to show that long-term symptom improvement after sinus balloon dilation is not worse than symptom improvement after functional endoscopic sinus surgery (FESS) and that fewer postoperative debridements are required after balloon dilation than after FESS.

Detailed description

This is a postmarket, multicenter, prospective, randomized clinical trial conducted at up to 15 US clinical sites comparing the efficacy of balloon sinus dilation with traditional endoscopic sinus surgery. The primary hypotheses were to demonstrate that: 1) long-term change in sinus symptoms after balloon dilation is not worse (non-inferior) than after FESS, and 2) balloon dilation is superior to FESS for a reduction in the number of postoperative debridements per patient. A minimum of 36 participants per arm is required to test the primary hypotheses. All participants will be followed through a minimum of 12 months post treatment.

Conditions

• Chronic Sinusitis

Interventions

Type	Name	Description
DEVICE	Balloon Sinus Dilation	Balloon sinus dilation using the XprESS Multi-Sinus Dilation Tool or the FinESS SInus Treatment
PROCEDURE	Functional Endoscopic Sinus Surgery	Endoscopic sinus surgery, specifically, maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy

Timeline

• Start date: 2011-12-01
• Primary completion: 2014-02-01
• Completion: 2014-05-01
• First posted: 2012-02-03
• Last updated: 2017-02-24
• Results posted: 2017-02-24

Locations

1 site across 1 country: United States