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Trans-Nasal Maxillary Multi-Sinus Balloon Dilation Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01612780
First Posted: June 6, 2012
Last Update Posted: May 22, 2014
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
The purpose of this study is to show clinically meaningful improvement in symptom severity after trans-nasal balloon dilation of the maxillary sinus outflow tract with or without balloon dilation of the frontal or sphenoid sinuses.

Condition Intervention
Sinusitis Device: XprESS Multi-Sinus Dilation Tool

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Trans-Nasal Maxillary Multi-Sinus Balloon Dilation Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change in quality of life [ Time Frame: 1 year post-procedure ]
  • Rate of revision/additional sinus surgery [ Time Frame: one year post-procedure ]

Enrollment: 81
Study Start Date: April 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: XprESS Multi-Sinus Dilation Tool
Balloon sinus dilation
Device: XprESS Multi-Sinus Dilation Tool
Sinus balloon dilation
Other Name: Sinus balloon dilation

  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 old or older
  • A candidate for trans-nasal balloon dilation of the maxillary sinus(es)

Exclusion Criteria:

  • Prior maxillary sinus surgery
  • Currently participating in other drug or device studies
  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): NCT01612780


Locations
United States, Minnesota
Entellus Medical
Plymouth, Minnesota, United States, 55447
Sponsors and Collaborators
Entellus Medical, Inc.
  More Information

Additional Information:
Publications:
Responsible Party: Entellus Medical, Inc.
ClinicalTrials.gov Identifier: NCT01612780     History of Changes
Other Study ID Numbers: 2233-001
First Submitted: June 1, 2012
First Posted: June 6, 2012
Last Update Posted: May 22, 2014
Last Verified: May 2014

Keywords provided by Entellus Medical, Inc.:
Sinusitis
Sinus balloon dilation patients

Additional relevant MeSH terms:
Sinusitis
Dilatation, Pathologic
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Pathological Conditions, Anatomical