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XprESS Maxillary 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: NCT01525862
Recruitment Status : Completed
First Posted : February 3, 2012
Last Update Posted : February 13, 2013
Sponsor:
Information provided by (Responsible Party):
Entellus Medical, Inc.

Tracking Information
First Submitted Date  ICMJE February 1, 2012
First Posted Date  ICMJE February 3, 2012
Last Update Posted Date February 13, 2013
Study Start Date  ICMJE December 2011
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2012)
Symptom improvement [ Time Frame: 6 months 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 XprESS Maxillary Balloon Dilation Study
Official Title  ICMJE XprESS Maxillary Sinus Balloon Dilation Study
Brief Summary This is a study looking at transnasal sinus balloon dilation without tissue removal treating the maxillary sinuses in patients with sinusitis. The study will be assessing symptomatic improvement post-procedure.
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 Chronic Sinusitis
Intervention  ICMJE Device: Sinus Balloon Dilation Tool
transnasal sinus balloon dilation procedure
Other Name: XprESS Multi-Sinus Balloon Dilation Tool
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   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
Estimated Enrollment  ICMJE
 (submitted: February 2, 2012)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 years or older
  • Patients with chronic sinusitis of the maxillary sinus(es)

Exclusion Criteria:

  • Fungal disease
  • Samter's triad
  • Hemophilia
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 NCT01525862
Other Study ID Numbers  ICMJE 2091-001
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 February 2013

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