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Randomized Evaluation of Maxillary Antrostomy Versus Ostial Dilation Efficacy Through Long-Term Follow-Up (REMODEL)

This study has been completed.
Information provided by (Responsible Party):
Entellus Medical, Inc. Identifier:
First received: February 1, 2012
Last updated: May 22, 2014
Last verified: May 2014
The objective of this study is to show that long-term symptom improvement following sinus balloon dilation is not worse than symptom improvement following functional endoscopic sinus surgery.

Condition Intervention
Chronic Sinusitis
Device: Balloon Sinus Dilation
Procedure: Functional Endoscopic Sinus Surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Entellus Medical, Inc.:

Primary Outcome Measures:
  • Symptom improvement [ Time Frame: one year ]

Enrollment: 151
Study Start Date: December 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Balloon Sinus Dilation
XprESS Multi-Sinus Dilation Balloon, FinESS Sinus Treatment
Device: Balloon Sinus Dilation
Balloon Sinus Dilation
Other Names:
  • XprESS Multi-Sinus Dialtion Tool
  • FinESS Sinus Treatment
Active Comparator: Functional Endoscopic Sinus Surgery Procedure: Functional Endoscopic Sinus Surgery
Endoscopic sinus surgery


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
  • maxillary sinus disease
  • chronic sinusitis

Exclusion Criteria:

  • fungal disease
  • Samter's triad
  • hemophilia
  • prior sinus surgery
  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: NCT01525849

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: NCT01525849     History of Changes
Other Study ID Numbers: 1984-001 
Study First Received: February 1, 2012
Last Updated: May 22, 2014

Additional relevant MeSH terms:
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases processed this record on February 20, 2017