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XprESS Maxillary Balloon Dilation Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01525862
First Posted: February 3, 2012
Last Update Posted: February 13, 2013
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.
Information provided by (Responsible Party):
Entellus Medical, Inc.
  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: None (Open Label)
Primary Purpose: Treatment
Official Title: XprESS Maxillary Sinus Balloon Dilation Study

Resource links provided by NLM:


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

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

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

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
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
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 ClinicalTrials.gov identifier (NCT number): NCT01525862


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

Additional Information:
Responsible Party: Entellus Medical, Inc.
ClinicalTrials.gov Identifier: NCT01525862     History of Changes
Other Study ID Numbers: 2091-001
First Submitted: February 1, 2012
First Posted: February 3, 2012
Last Update Posted: February 13, 2013
Last Verified: February 2013

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