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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Entellus Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01525849
First received: February 1, 2012
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

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 ] [ Designated as safety issue: No ]

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

  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
  • 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 ClinicalTrials.gov identifier: NCT01525849

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

Additional Information:
Publications:
Responsible Party: Entellus Medical, Inc.
ClinicalTrials.gov Identifier: NCT01525849     History of Changes
Other Study ID Numbers: 1984-001
Study First Received: February 1, 2012
Last Updated: May 22, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sinusitis
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014