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

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.

Condition or disease Intervention/treatment
Chronic Sinusitis Device: Sinus Balloon Dilation Tool

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: XprESS Maxillary Sinus Balloon Dilation Study
Study Start Date : December 2011
Primary Completion Date : January 2013
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis
U.S. FDA Resources

Intervention Details:
    Device: Sinus Balloon Dilation Tool
    transnasal sinus balloon dilation procedure
    Other Name: XprESS Multi-Sinus Balloon Dilation Tool

Primary Outcome Measures :
  1. Symptom improvement [ Time Frame: 6 months post-procedure ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Fungal disease
  • Samter's triad
  • Hemophilia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01525862

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

Additional Information:
Responsible Party: Entellus Medical, Inc. Identifier: NCT01525862     History of Changes
Other Study ID Numbers: 2091-001
First Posted: February 3, 2012    Key Record Dates
Last Update Posted: February 13, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases