CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 175 enrolled
Drug / intervention
XprESS Balloon Devicedevice
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/NCT01115309
NCT01115309N/ACompleted
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XprESS Registry Study

Entellus Medical, Inc.·interventional·Posted May 4, 2010·Updated Oct 27, 2020

In Brief

A clinical study evaluating XprESS Balloon Device for Sinusitis. Completed, enrolled 175 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSinusitis
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 4, 2010
Enrollment StartApr 1, 2010
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 16.2 years ago

Interventions

XprESS Balloon Devicedevice

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).