This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

XprESS Maxillary Balloon Dilation Study

This study has been completed.
Information provided by (Responsible Party):
Entellus Medical, Inc. Identifier:
First received: February 1, 2012
Last updated: February 12, 2013
Last verified: February 2013
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: None (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 ]

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT01525862

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

Additional Information:
Responsible Party: Entellus Medical, Inc. Identifier: NCT01525862     History of Changes
Other Study ID Numbers: 2091-001
Study First Received: February 1, 2012
Last Updated: February 12, 2013

Additional relevant MeSH terms:
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases processed this record on September 21, 2017