search
Back to results

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

Primary Purpose

Chronic Sinusitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Balloon Sinus Dilation
Functional Endoscopic Sinus Surgery
Sponsored by
Entellus Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Sinusitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years or older
  • maxillary sinus disease
  • chronic sinusitis

Exclusion Criteria:

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

Sites / Locations

  • Entellus Medical

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Balloon Sinus Dilation

Functional Endoscopic Sinus Surgery

Arm Description

XprESS Multi-Sinus Dilation Balloon, FinESS Sinus Treatment

Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.

Outcomes

Primary Outcome Measures

Sinus Symptom Improvement
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
Number of postoperative debridements per participant

Secondary Outcome Measures

Revision Rate
Number of participants requiring repeat sinus procedures
Complication Rate
Number of participants experiencing 1 or more serious adverse events related to the device and/or procedure
Recovery Time
Mean time (days) after procedure for participants to return to normal activities

Full Information

First Posted
February 1, 2012
Last Updated
January 4, 2017
Sponsor
Entellus Medical, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT01525849
Brief Title
Randomized Evaluation of Maxillary Antrostomy Versus Ostial Dilation Efficacy Through Long-Term Follow-Up
Acronym
REMODEL
Official Title
Randomized Evaluation of Maxillary Antrostomy Versus Ostial Dilation Efficacy Through Long-Term Follow-Up
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Entellus Medical, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Sinusitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Balloon Sinus Dilation
Arm Type
Active Comparator
Arm Description
XprESS Multi-Sinus Dilation Balloon, FinESS Sinus Treatment
Arm Title
Functional Endoscopic Sinus Surgery
Arm Type
Active Comparator
Arm Description
Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
Intervention Type
Device
Intervention Name(s)
Balloon Sinus Dilation
Intervention Description
Balloon sinus dilation using the XprESS Multi-Sinus Dilation Tool or the FinESS SInus Treatment
Intervention Type
Procedure
Intervention Name(s)
Functional Endoscopic Sinus Surgery
Intervention Description
Endoscopic sinus surgery, specifically, maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy
Primary Outcome Measure Information:
Title
Sinus Symptom Improvement
Description
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).
Time Frame
Baseline and 1-year
Title
Debridements
Description
Number of postoperative debridements per participant
Time Frame
1-year
Secondary Outcome Measure Information:
Title
Revision Rate
Description
Number of participants requiring repeat sinus procedures
Time Frame
1-year
Title
Complication Rate
Description
Number of participants experiencing 1 or more serious adverse events related to the device and/or procedure
Time Frame
Duration of study (minimum of 12 months)
Title
Recovery Time
Description
Mean time (days) after procedure for participants to return to normal activities
Time Frame
6-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or older maxillary sinus disease chronic sinusitis Exclusion Criteria: fungal disease Samter's triad hemophilia prior sinus surgery
Facility Information:
Facility Name
Entellus Medical
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55447
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23920419
Citation
Cutler J, Bikhazi N, Light J, Truitt T, Schwartz M; REMODEL Study Investigators. Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: a prospective, multicenter, randomized, controlled trial. Am J Rhinol Allergy. 2013 Sep-Oct;27(5):416-22. doi: 10.2500/ajra.2013.27.3970. Epub 2013 Aug 5.
Results Reference
result
PubMed Identifier
24823902
Citation
Bikhazi N, Light J, Truitt T, Schwartz M, Cutler J; REMODEL Study Investigators. Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: a prospective, multicenter, randomized, controlled trial with 1-year follow-up. Am J Rhinol Allergy. 2014 Jul-Aug;28(4):323-9. doi: 10.2500/ajra.2014.28.4064. Epub 2014 May 12.
Results Reference
result
PubMed Identifier
26228589
Citation
Chandra RK, Kern RC, Cutler JL, Welch KC, Russell PT. REMODEL larger cohort with long-term outcomes and meta-analysis of standalone balloon dilation studies. Laryngoscope. 2016 Jan;126(1):44-50. doi: 10.1002/lary.25507. Epub 2015 Jul 30.
Results Reference
result
Links:
URL
http://www.entellusmedical.com
Description
sponsor website

Learn more about this trial

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

We'll reach out to this number within 24 hrs