CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 71 enrolled
Drug / intervention
RS-Series Rhinosinusitis Treatment System +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/NCT00645762
NCT00645762Phase 2Completed
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Balloon REmodeling Antrostomy THErapy Study (BREATHE I)

Entellus Medical, Inc.·interventional·Posted Mar 28, 2008·Updated Jul 29, 2013

In Brief

A Phase 2 clinical trial evaluating RS-Series Rhinosinusitis Treatment System and FinESS Balloon for Sinusitis. Completed, enrolled 71 participants across 13 sites.

Detailed Summary

This study is designed to evaluate safety and effectiveness of a less invasive procedure to treat maxillary only, or maxillary and anterior ethmoid, chronic sinusitis. Additionally, this study will assess the feasibility of performing the procedure under local anesthesia.

Study Details

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

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 28, 2008
Enrollment StartSep 1, 2007
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 18.3 years ago

Interventions

RS-Series Rhinosinusitis Treatment Systemdevice

Single arm

FinESS Balloondevice