NCT00645762

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 28, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

July 29, 2013

Completed
Last Updated

July 29, 2013

Status Verified

June 1, 2013

Enrollment Period

2.8 years

First QC Date

March 20, 2008

Results QC Date

March 15, 2013

Last Update Submit

June 20, 2013

Conditions

Sinusitis

Keywords

Chronic rhinosinusitisChronic sinusitisMaxillary sinusAnterior ethmoid sinusEthmoid infundibulumBalloon dilationEndoscopic visualizationLocal anesthesiaCanine fossaLess invasive

Outcome Measures

Primary Outcomes (3)

  • Incidences of Device-related or Procedure-related Complications

    Through 12 months post-procedure

  • 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

  • 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

Study Arms (1)

Balloon Dilation

ACTIVE COMPARATOR

Balloon dilation with FinESS device

Device: RS-Series Rhinosinusitis Treatment SystemDevice: FinESS Balloon

Interventions

RS-Series Rhinosinusitis Treatment SystemDEVICE

Single arm

Balloon Dilation
FinESS BalloonDEVICE
Balloon Dilation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • 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.
  • Evidence of maxillary sinus air/liquid level.

You may not qualify if:

  • 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)
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Central California Ear, Nose and Throat Medical Group

Fresno, California, 93720, United States

Location

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

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

Saint Cloud, Minnesota, 56303, United States

Location

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

Lake Success, New York, 11042, United States

Location

Charlotte Eye, Ear, Nose & Throat Associates

Charlotte, North Carolina, 28210, United States

Location

Midwest Ear, Nose, and Throat

Sioux Falls, South Dakota, 57108, United States

Location

Holston Medical Group

Kingsport, Tennessee, 37660, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Austin Ear, Nose & Throat Clinic

Austin, Texas, 78705-1023, United States

Location

Texas Sinus Center

Boerne, Texas, 78006, United States

Location

San Antonio Ear, Nose, and Throat Research

San Antonio, Texas, 78229, United States

Location

Ear, Nose, Throat & Plastic Surgery Associates, PS

Auburn, Washington, 98002, United States

Location

Related Publications (1)

  • 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.

    PMID: 19419611DERIVED

MeSH Terms

Conditions

Sinusitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Results Point of Contact

Title
Entellus Medical
Organization
Entellus Medical
763-463-1599

Study Officials

  • James Stankiewicz, MD

    Loyola University Medical Center, Maywood, IL

    PRINCIPAL INVESTIGATOR

  • Thomas Tami, MD

    Cincinnati Sinus Institute, Cincinnati OH

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2008

First Posted

March 28, 2008

Study Start

September 1, 2007

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

July 29, 2013

Results First Posted

July 29, 2013

Record last verified: 2013-06

Locations

US(13)