CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 151 enrolled
Drug / intervention
Balloon Sinus Dilation +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01525849
NCT01525849N/ACompleted
CompareCT.gov

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

Entellus Medical, Inc.·interventional·Posted Feb 3, 2012·Updated Feb 24, 2017

In Brief

A clinical study evaluating Balloon Sinus Dilation and Functional Endoscopic Sinus Surgery for Chronic Sinusitis. Completed, enrolled 151 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Sinusitis
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 3, 2012
Enrollment StartDec 1, 2011
Primary CompletionFeb 1, 2014
Study CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 14.4 years ago

Interventions

Balloon Sinus Dilationdevice

Balloon sinus dilation using the XprESS Multi-Sinus Dilation Tool or the FinESS SInus Treatment

Functional Endoscopic Sinus Surgeryprocedure

Endoscopic sinus surgery, specifically, maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy