XprESS Maxillary Balloon Dilation Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Entellus Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01525862
First received: February 1, 2012
Last updated: February 12, 2013
Last verified: February 2013
  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: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT01525862

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

Additional Information:
No publications provided

Responsible Party: Entellus Medical, Inc.
ClinicalTrials.gov Identifier: NCT01525862     History of Changes
Other Study ID Numbers: 2091-001
Study First Received: February 1, 2012
Last Updated: February 12, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 16, 2014