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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00645762
Other study ID # 1156-001
Secondary ID
Status Completed
Phase Phase 2
First received March 20, 2008
Last updated June 20, 2013
Start date September 2007
Est. completion date June 2010

Study information

Verified date June 2013
Source Entellus Medical, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 71
Est. completion date June 2010
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
RS-Series Rhinosinusitis Treatment System
Single arm
FinESS Balloon


Locations

Country Name City State
United States Ear, Nose, Throat & Plastic Surgery Associates, PS Auburn Washington
United States Austin Ear, Nose & Throat Clinic Austin Texas
United States Texas Sinus Center Boerne Texas
United States Charlotte Eye, Ear, Nose & Throat Associates Charlotte North Carolina
United States NorthShore University HealthSystem Evanston Illinois
United States Central California Ear, Nose and Throat Medical Group Fresno California
United States Holston Medical Group Kingsport Tennessee
United States Otolaryngology-Facial Plastic Surgery of Long Island P.C. Lake Success New York
United States Loyola University Medical Center Maywood Illinois
United States Vanderbilt University Medical Center Nashville Tennessee
United States St. Cloud Ear, Nose & Throat - Head and Neck Clinic Saint Cloud Minnesota
United States San Antonio Ear, Nose, and Throat Research San Antonio Texas
United States Midwest Ear, Nose, and Throat Sioux Falls South Dakota

Sponsors (1)

Lead Sponsor Collaborator
Entellus Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidences of Device-related or Procedure-related Complications Through 12 months post-procedure Yes
Primary Patency of the Treated Area as Verified by CT Scan Post-procedure Patency was assessed using a CT scan 3 months post-procedure. The osteomeatal complex was assessed for patency by physicians. Post-treatment at 3 months No
Primary Symptomatic Score Change- Sinonasal Outcome (SNOT) 20 Score Improvement 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. Post-treatment through 12 months No
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