Trans-Nasal Maxillary Multi-Sinus Balloon Dilation Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Entellus Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01612780
First received: June 1, 2012
Last updated: May 20, 2014
Last verified: May 2014
  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: 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 ] [ Designated as safety issue: No ]
  • Rate of revision/additional sinus surgery [ Time Frame: one year post-procedure ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: June 1, 2012
Last Updated: May 20, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 29, 2014