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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Entellus Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01525849
First received: February 1, 2012
Last updated: February 12, 2013
Last verified: February 2013
History of Changes
  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: Sinus balloon 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:

MedlinePlus related topics: Endoscopy Sinusitis
U.S. FDA Resources

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

Primary Outcome Measures:
  • Symptom improvement [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: December 2011
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sinus balloon dilation Device: Sinus balloon dilation
Sinus balloon dilation
Other Names:
  • FinESS Sinus Treatment
  • XprESS Multi-Sinus Dialtion Tool
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
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:
sponsor website  This link exits the ClinicalTrials.gov site
study screening website  This link exits the ClinicalTrials.gov site

No publications provided

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: February 12, 2013
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 May 16, 2013