Trans-Nasal Maxillary Multi-Sinus Balloon Dilation Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Entellus Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01612780
First received: June 1, 2012
Last updated: February 12, 2013
Last verified: February 2013
  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 ]

Estimated Enrollment: 120
Study Start Date: April 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: September 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
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:
No publications provided

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: February 12, 2013
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 April 15, 2014