XprESS Maxillary Balloon Dilation Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Entellus Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01525862
First received: February 1, 2012
Last updated: February 12, 2013
Last verified: February 2013

February 1, 2012
February 12, 2013
December 2011
January 2013   (final data collection date for primary outcome measure)
Symptom improvement [ Time Frame: 6 months post-procedure ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01525862 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
XprESS Maxillary Balloon Dilation Study
XprESS Maxillary Sinus Balloon Dilation Study

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Sinusitis
Device: Sinus Balloon Dilation Tool
transnasal sinus balloon dilation procedure
Other Name: XprESS Multi-Sinus Balloon Dilation Tool
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
January 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Fungal disease
  • Samter's triad
  • Hemophilia
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01525862
2091-001
No
Entellus Medical, Inc.
Entellus Medical, Inc.
Not Provided
Not Provided
Entellus Medical, Inc.
February 2013

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