Balloon REmodeling Antrostomy THErapy Study

NCT ID: NCT00645762

Last Updated: 2013-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2010-06-30

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Balloon Dilation

Balloon dilation with FinESS device

Group Type: ACTIVE_COMPARATOR

RS-Series Rhinosinusitis Treatment System

Intervention Type: DEVICE

Single arm

FinESS Balloon

Intervention Type: DEVICE

Interventions

RS-Series Rhinosinusitis Treatment System

Single arm

Intervention Type: DEVICE

FinESS Balloon

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subjects age 18 or older with chronic rhinosinusitis of the maxillary or maxillary and anterior ethmoid sinuses
• A CT scan taken after maximal medical therapy (e.g., local or systemic antibiotics, topical steroids, etc.) must show one of the following:

1. Narrowing of the outflow tract of the maxillary sinus ostium or infundibulum with mucosal thickening of 2 mm or greater of the maxillary sinus antrum.

2. Evidence of maxillary sinus air/liquid level.

Exclusion Criteria

• Evidence of chronic posterior ethmoid, sphenoid or frontal sinusitis
• Inability to understand the study or a history of non-compliance with medical advice
• Unwilling or unable to sign Informed Consent Form (ICF)
• Currently enrolled in any other pre-approval investigational study (does not apply to long-term post-market studies)
• History of any cognitive or mental health status that would interfere with study participation
• Previous sinus surgery or intervention including sinuplasty
• Pregnant women
• Severe septal deviation causing obstruction of the ostiomeatal unit
• History of primary ciliary dysfunction
• Hemophilia
• Currently undergoing or in the past 6 months had undergone chemotherapy for cancer or radiation therapy in the head or neck region
• History of cystic fibrosis
• Known Sampter's Triad (aspirin sensitivity, asthma, sinonasal polyposis)
• Known sinonasal tumors or obstructive lesions
• History of mid facial fractures or orthognathic surgery (does not include nasal fracture)
• History of insulin dependent diabetes
• Not able to stop anti-coagulant (e.g., warfarin) until the International Normalized Ratio(INR) is below 1.5
• Not able to stop anti-platelet (e.g., clopidogrel, aspirin, etc.) for at least 14 days prior to study procedure
• Not able to stop any non-steroidal anti-inflammatory medications and homeopathic medications for at least 14 days prior to the study procedure
• Presence of nasal polyps that may interfere with the treatment procedure
• Presence of features consistent with sinus fungal disease on CT or physical examination

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Entellus Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Stankiewicz, MD

Role: PRINCIPAL_INVESTIGATOR

Loyola University Medical Center, Maywood, IL

Thomas Tami, MD

Role: PRINCIPAL_INVESTIGATOR

Cincinnati Sinus Institute, Cincinnati OH

Locations

Central California Ear, Nose and Throat Medical Group

Fresno, California, United States

NorthShore University HealthSystem

Evanston, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

St. Cloud Ear, Nose & Throat - Head and Neck Clinic

Saint Cloud, Minnesota, United States

Otolaryngology-Facial Plastic Surgery of Long Island P.C.

Lake Success, New York, United States

Charlotte Eye, Ear, Nose & Throat Associates

Charlotte, North Carolina, United States

Midwest Ear, Nose, and Throat

Sioux Falls, South Dakota, United States

Holston Medical Group

Kingsport, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Austin Ear, Nose & Throat Clinic

Austin, Texas, United States

Texas Sinus Center

Boerne, Texas, United States

San Antonio Ear, Nose, and Throat Research

San Antonio, Texas, United States

Ear, Nose, Throat & Plastic Surgery Associates, PS

Auburn, Washington, United States

Countries

United States

References

Stankiewicz J, Tami T, Truitt T, Atkins J, Liepert D, Winegar B. Transantral, endoscopically guided balloon dilatation of the ostiomeatal complex for chronic rhinosinusitis under local anesthesia. Am J Rhinol Allergy. 2009 May-Jun;23(3):321-7. doi: 10.2500/ajra.2009.23.3274. Epub 2009 Jan 16.

Reference Type: DERIVED

PMID: 19419611 (View on PubMed)

Other Identifiers

1156-001

Identifier Type: -

Identifier Source: org_study_id