CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 63 enrolled
Drug / intervention
Stratus Microflow Ethmoid Spacerdevice
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/NCT00791934
NCT00791934N/ACompleted
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Clinical Study of Safety and Efficacy for the Relieva Stratus With Elution of Triamcinolone Acetonide (Kenalog-40)

Integra LifeSciences Corporation·interventional·Posted Nov 17, 2008·Updated Aug 6, 2024

In Brief

A clinical study evaluating Stratus Microflow Ethmoid Spacer for Sinusitis. Completed, enrolled 63 participants across 1 site.

Detailed Summary

Study Design: A non-randomized, multi-center, prospective, clinical study intended to evaluate the safety and efficacy of treating the ethmoid sinuses with the Ethmoid Sinus Spacer and Access System used for the local delivery of Triamcinolone Acetonide, over a period of 28 days.

Study Details

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

Timeline

N/ACompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 17, 2008
Enrollment StartAug 1, 2008
Primary CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 17.6 years ago

Interventions

Stratus Microflow Ethmoid Spacerdevice

The Spacer is inserted surgically into the ethmoid complex through the use of a sinus access system. Triamcinolone acetonide will be administered into the Spacer for this investigational study. The Spacer will be left in the ethmoid sinus for a period of 28 days. At the end of the implant period, the device is removed with standard instrumentation, during a follow-up office visit.