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Trans-Nasal Maxillary Multi-Sinus Balloon Dilation Study

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ClinicalTrials.gov Identifier: NCT01612780
Recruitment Status : Completed
First Posted : June 6, 2012
Last Update Posted : May 22, 2014
Sponsor:
Information provided by (Responsible Party):
Entellus Medical, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Sinusitis Device: XprESS Multi-Sinus Dilation Tool Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Trans-Nasal Maxillary Multi-Sinus Balloon Dilation Study
Study Start Date : April 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis

Arm Intervention/treatment
Experimental: XprESS Multi-Sinus Dilation Tool
Balloon sinus dilation
Device: XprESS Multi-Sinus Dilation Tool
Sinus balloon dilation
Other Name: Sinus balloon dilation




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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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.

Additional Information:
Publications of Results:
Responsible Party: Entellus Medical, Inc.
ClinicalTrials.gov Identifier: NCT01612780     History of Changes
Other Study ID Numbers: 2233-001
First Posted: June 6, 2012    Key Record Dates
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