NCT01612780

Trans-Nasal Maxillary Multi-Sinus Balloon Dilation Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Entellus Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to show clinically meaningful improvement in symptom severity after transnasal balloon dilation of the maxillary sinus outflow tract with or without balloon dilation of the frontal or sphenoid sinuses.

Detailed description

This is a prospective, non-randomized, single arm, post-approval study conducted under a common protocol designed to evaluate outcomes following trans-nasal balloon dilation of the maxillary sinus outflow tract with or without concurrent balloon dilation of the frontal or sphenoid sinuses and without any concomitant conventional sinus surgery (ie, uncinectomy, complete or partial ethmoidectomy).

Conditions

• Sinusitis

Interventions

Type	Name	Description
DEVICE	XprESS Multi-Sinus Dilation Tool	Sinus balloon dilation

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2012-06-06
• Last updated: 2020-10-22
• Results posted: 2020-10-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study