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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
History of Changes
  Purpose

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.


Condition Intervention
Chronic Sinusitis
 Device: Sinus Balloon Dilation Tool

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: XprESS Maxillary Sinus Balloon Dilation Study

Resource links provided by NLM:

MedlinePlus related topics: Sinusitis
U.S. FDA Resources

Further study details as provided by Entellus Medical, Inc.:

Primary Outcome Measures:
  • Symptom improvement [ Time Frame: 6 months post-procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: December 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Sinus Balloon Dilation Tool
    transnasal sinus balloon dilation procedure
    Other Name: XprESS Multi-Sinus Balloon Dilation Tool
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Fungal disease
  • Samter's triad
  • Hemophilia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01525862

Locations
United States, Minnesota
Entellus Medical
Maple Grove, Minnesota, United States
Sponsors and Collaborators
Entellus Medical, Inc.
  More Information

Additional Information:
Sponsor website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Entellus Medical, Inc.
ClinicalTrials.gov Identifier: NCT01525862     History of Changes
Other Study ID Numbers: 2091-001
Study First Received: February 1, 2012
Last Updated: February 12, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sinusitis
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
 Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013