NCT01115309

XprESS Registry Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 175 (actual)
• Sponsor: Entellus Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, non-randomized, multi-center study to assess safety and long-term patency of the ostia treated with the XprESS device per the device indication for use (IFU).

Detailed description

Endoscopic balloon-only and hybrid-balloon procedures involving dilation of the frontal recesses, maxillary ostia, and/or sphenoid sinus ostia were performed in 175 patients. One-month follow-up was required for all patients. The first 50 patients enrolled also consented to a 1-year follow-up. Complications and sinus symptom severity were assessed at the 1-month visit. Symptom severity and ostial patency of the treated sinuses were evaluated at the 1-year visit.

Conditions

• Sinusitis

Interventions

Type	Name	Description
DEVICE	XprESS Balloon Device	Sinus dilation completed with the XprESS Balloon Device with or without additional endoscopic sinus surgery procedures (dilation of the frontal recesses, maxillary ostia, and/or sphenoid sinus ostia).

Timeline

• Start date: 2010-04-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2010-05-04
• Last updated: 2020-10-27
• Results posted: 2020-10-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study