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Clinical Study of Safety and Efficacy for the Relieva Stratus With Elution of Triamcinolone Acetonide

NCT00791934 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2024-08-06

Study results available
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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.

Conditions

  • Sinusitis

Interventions

DEVICE

Stratus Microflow Ethmoid Spacer

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.

Sponsors & Collaborators

  • Acclarent

    collaborator INDUSTRY

  • Integra LifeSciences Corporation

    lead INDUSTRY

Principal Investigators

  • Peter Catalano, MD · Lahey Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00791934 on ClinicalTrials.gov