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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: January 4, 2017
Last verified: January 2017
  Purpose
The objective of this study is to show that long-term symptom improvement after sinus balloon dilation is not worse than symptom improvement after functional endoscopic sinus surgery (FESS) and that fewer postoperative debridements are required after balloon dilation than after FESS.

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
Official Title: Randomized Evaluation of Maxillary Antrostomy Versus Ostial Dilation Efficacy Through Long-Term Follow-Up

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Sinus Symptom Improvement [ Time Frame: Baseline and 1-year ]
    Change from baseline in overall 20-item Sino-Nasal Outcome Test (SNOT-20) score. The SNOT-20 is a validated patient reported survey of 20 items related to sinonasal symptoms and severity assessed over the previous 2 weeks. Each item is scored from 0 (no problem) to 5 (problem as bad as it can be). The individual item scores are averaged to provide and overall score that ranges from 0 (best) to 5 (worst).

  • Debridements [ Time Frame: 1-year ]
    Number of postoperative debridements per participant


Secondary Outcome Measures:
  • Revision Rate [ Time Frame: 1-year ]
    Number of participants requiring repeat sinus procedures

  • Complication Rate [ Time Frame: Duration of study (minimum of 12 months) ]
    Number of participants experiencing 1 or more serious adverse events related to the device and/or procedure

  • Recovery Time [ Time Frame: 6-months ]
    Mean time (days) after procedure for participants to return to normal activities


Enrollment: 151
Study Start Date: December 2011
Study Completion Date: May 2014
Primary Completion Date: February 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 using the XprESS Multi-Sinus Dilation Tool or the FinESS SInus Treatment
Active Comparator: Functional Endoscopic Sinus Surgery
Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
Procedure: Functional Endoscopic Sinus Surgery
Endoscopic sinus surgery, specifically, maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy

Detailed Description:
This is a postmarket, multicenter, prospective, randomized clinical trial conducted at up to 15 US clinical sites comparing the efficacy of balloon sinus dilation with traditional endoscopic sinus surgery. The primary hypotheses were to demonstrate that: 1) long-term change in sinus symptoms after balloon dilation is not worse (non-inferior) than after FESS, and 2) balloon dilation is superior to FESS for a reduction in the number of postoperative debridements per patient. A minimum of 36 participants per arm is required to test the primary hypotheses. All participants will be followed through a minimum of 12 months post treatment.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Plymouth, Minnesota, United States, 55447
Sponsors and Collaborators
Entellus Medical, Inc.