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Balloon REmodeling Antrostomy THErapy Study

NCT00645762 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2013-07-29

Study results available
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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.

Conditions

  • Sinusitis

Interventions

DEVICE

RS-Series Rhinosinusitis Treatment System

Single arm

DEVICE

FinESS Balloon

Sponsors & Collaborators

  • Entellus Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • James Stankiewicz, MD · Loyola University Medical Center, Maywood, IL

  • Thomas Tami, MD · Cincinnati Sinus Institute, Cincinnati OH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2010-06-30
Completion
2010-06-30

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 NCT00645762 on ClinicalTrials.gov