Balloon REmodeling Antrostomy THErapy Study

Phase 2

Completed

Conditions: Sinusitis

Interventions: Device: RS-Series Rhinosinusitis Treatment System
Device: FinESS Balloon

Registration Number: NCT00645762

Lead Sponsor: Entellus Medical, Inc.

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 71

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Balloon Dilation	FinESS Balloon	Balloon dilation with FinESS device
Balloon Dilation	RS-Series Rhinosinusitis Treatment System	Balloon dilation with FinESS device

Primary Outcome Measures

Name	Time	Method
Patency of the Treated Area as Verified by CT Scan	Post-treatment at 3 months	Post-procedure Patency was assessed using a CT scan 3 months post-procedure. The osteomeatal complex was assessed for patency by physicians.
Symptomatic Score Change- Sinonasal Outcome (SNOT) 20 Score Improvement	Post-treatment through 12 months	Symptomatic change in SNOT 20 scores on a 5-point Likert scale where "0" = no problem to "5" = problem as bad as it can be were calculated. Baseline scores and 12 month post-procedure follow-up scores were calculated and compared. A score reduction of at least 0.8 (-0.8) from baseline to 12 months is considered statistically significant and clinically impactful.
Incidences of Device-related or Procedure-related Complications	Through 12 months post-procedure

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (13): Midwest Ear, Nose, and Throat
🇺🇸
Sioux Falls, South Dakota, United States
Central California Ear, Nose and Throat Medical Group
🇺🇸
Fresno, California, United States
Loyola University Medical Center
🇺🇸
Maywood, Illinois, United States
Holston Medical Group
🇺🇸
Kingsport, Tennessee, United States
Vanderbilt University Medical Center
🇺🇸
Nashville, Tennessee, United States
San Antonio Ear, Nose, and Throat Research
🇺🇸
San Antonio, Texas, 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
NorthShore University HealthSystem
🇺🇸
Evanston, Illinois, United States
Charlotte Eye, Ear, Nose & Throat Associates
🇺🇸
Charlotte, North Carolina, United States
Texas Sinus Center
🇺🇸
Boerne, Texas, United States
Ear, Nose, Throat & Plastic Surgery Associates, PS
🇺🇸
Auburn, Washington, United States
Austin Ear, Nose & Throat Clinic
🇺🇸
Austin, Texas, United States