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Trans-Nasal Maxillary Multi-Sinus Balloon Dilation Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01612780
Recruitment Status : Completed
First Posted : June 6, 2012
Last Update Posted : May 22, 2014
Sponsor:
Information provided by (Responsible Party):
Entellus Medical, Inc.

Tracking Information
First Submitted Date  ICMJE June 1, 2012
First Posted Date  ICMJE June 6, 2012
Last Update Posted Date May 22, 2014
Study Start Date  ICMJE April 2012
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2012)
  • Change in quality of life [ Time Frame: 1 year post-procedure ]
  • Rate of revision/additional sinus surgery [ Time Frame: one year post-procedure ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trans-Nasal Maxillary Multi-Sinus Balloon Dilation Study
Official Title  ICMJE Trans-Nasal Maxillary Multi-Sinus Balloon Dilation Study
Brief Summary The purpose of this study is to show clinically meaningful improvement in symptom severity after trans-nasal balloon dilation of the maxillary sinus outflow tract with or without balloon dilation of the frontal or sphenoid sinuses.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sinusitis
Intervention  ICMJE Device: XprESS Multi-Sinus Dilation Tool
Sinus balloon dilation
Other Name: Sinus balloon dilation
Study Arms  ICMJE Experimental: XprESS Multi-Sinus Dilation Tool
Balloon sinus dilation
Intervention: Device: XprESS Multi-Sinus Dilation Tool
Publications * Gould J, Alexander I, Tomkin E, Brodner D. In-office, multisinus balloon dilation: 1-Year outcomes from a prospective, multicenter, open label trial. Am J Rhinol Allergy. 2014 Mar-Apr;28(2):156-63. doi: 10.2500/ajra.2014.28.4043. Epub 2014 Feb 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 20, 2014)
81
Original Estimated Enrollment  ICMJE
 (submitted: June 4, 2012)
120
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 years old or older
  • A candidate for trans-nasal balloon dilation of the maxillary sinus(es)

Exclusion Criteria:

  • Prior maxillary sinus surgery
  • Currently participating in other drug or device studies
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01612780
Other Study ID Numbers  ICMJE 2233-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Entellus Medical, Inc.
Study Sponsor  ICMJE Entellus Medical, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Entellus Medical, Inc.
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP