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

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ClinicalTrials.gov Identifier: NCT01525849
Recruitment Status : Completed
First Posted : February 3, 2012
Results First Posted : February 24, 2017
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):
Entellus Medical, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Sinusitis
Interventions Device: Balloon Sinus Dilation
Procedure: Functional Endoscopic Sinus Surgery
Enrollment 151
Recruitment Details Participants were screened, randomized, treated, and followed at 14 US centers from June 2011 to May 2014.
Pre-assignment Details After screening, informed consent, and baseline measures, participants were randomized 1:1 to balloon sinus dilation or FESS. The assigned procedure was to be performed within 60 days of randomization.
Arm/Group Title Balloon Sinus Dilation Functional Endoscopic Sinus Surgery
Hide Arm/Group Description Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
Period Title: Overall Study
Started 76 75
Treated 74 [1] 61 [2]
6-Months 73 60
Completed 71 59
Not Completed 5 16
Reason Not Completed
Lost to Follow-up             3             2
Withdrawal by Subject             1             9
Unrelated medical issue (not treated)             1             2
Anatomic exclusion criteria identified             0             3
[1]
2 withdrew before treatment: 1 didn't want balloon dilation, 1 unrelated medical issue.
[2]
14 withdrew before treatment: 8 didn't want FESS, 1 too busy, 2 medical issues, 3 excl. criteria.
Arm/Group Title Balloon Sinus Dilation Functional Endoscopic Sinus Surgery Total
Hide Arm/Group Description Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools. Total of all reporting groups
Overall Number of Baseline Participants 74 61 135
Hide Baseline Analysis Population Description
All treated participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 74 participants 61 participants 135 participants
46.1  (13.6) 47.8  (14.1) 46.9  (13.8)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 61 participants 135 participants
Female
48
  64.9%
36
  59.0%
84
  62.2%
Male
26
  35.1%
25
  41.0%
51
  37.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 61 participants 135 participants
Hispanic or Latino
6
   8.1%
5
   8.2%
11
   8.1%
Not Hispanic or Latino
68
  91.9%
56
  91.8%
124
  91.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 61 participants 135 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
4
   5.4%
1
   1.6%
5
   3.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   2.7%
4
   6.6%
6
   4.4%
White
65
  87.8%
56
  91.8%
121
  89.6%
More than one race
3
   4.1%
0
   0.0%
3
   2.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 74 participants 61 participants 135 participants
74 61 135
Sino-Nasal Outcome Test (SNOT-20) overall score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 74 participants 61 participants 135 participants
2.49  (0.88) 2.52  (0.83) 2.50  (0.85)
[1]
Measure Description: 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 an overall score that ranges from 0 (best) to 5 (worst).
1.Primary Outcome
Title Sinus Symptom Improvement
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with matched pair SNOT-20 data at baseline and 1-year.
Arm/Group Title Balloon Sinus Dilation Functional Endoscopic Sinus Surgery
Hide Arm/Group Description:
Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment
Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
Overall Number of Participants Analyzed 69 58
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change from baseline -1.59  (1.08) -1.60  (1.00)
Mean overall SNOT-20 score at 1-year 0.88  (0.91) 0.88  (0.76)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balloon Sinus Dilation, Functional Endoscopic Sinus Surgery
Comments Non-inferiority test to demonstrate that the long-term (1-year) change in sinus symptoms (overall SNOT-20 score) after balloon dilation is not worse than after FESS.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Significance level=0.025 (1-sided alpha), power=90%, delta=0.8, true difference=0, SD for both arms=1.0. A total sample size of 72 participants (36 per arm) was required to test the hypothesis.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
2.Primary Outcome
Title Debridements
Hide Description Number of postoperative debridements per participant
Time Frame 1-year
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Balloon Sinus Dilation Functional Endoscopic Sinus Surgery
Hide Arm/Group Description:
Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment
Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
Overall Number of Participants Analyzed 74 61
Mean (Standard Deviation)
Unit of Measure: debridements per participant
0.23  (0.65) 1.03  (0.87)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balloon Sinus Dilation, Functional Endoscopic Sinus Surgery
Comments Test for superiority of balloon dilation over FESS. Significance level=0.025 (1-sided alpha), power=90%, BD estimate=0.5, FESS estimate=1.5, SD for both arms=1.0. A total sample size of 46 participants (23 per arm) was required to test the hypothesis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
3.Secondary Outcome
Title Revision Rate
Hide Description Number of participants requiring repeat sinus procedures
Time Frame 1-year
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with 1-year follow-up (or a revision surgery before 1-year follow-up if no 1-year follow-up).
Arm/Group Title Balloon Sinus Dilation Functional Endoscopic Sinus Surgery
Hide Arm/Group Description:
Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment
Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
Overall Number of Participants Analyzed 71 59
Measure Type: Count of Participants
Unit of Measure: Participants
1
   1.4%
1
   1.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balloon Sinus Dilation, Functional Endoscopic Sinus Surgery
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.628
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Complication Rate
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Balloon Sinus Dilation Functional Endoscopic Sinus Surgery
Hide Arm/Group Description:
Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment
Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
Overall Number of Participants Analyzed 76 75
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Recovery Time
Hide Description Mean time (days) after procedure for participants to return to normal activities
Time Frame 6-months
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with 6-month follow-up.
Arm/Group Title Balloon Sinus Dilation Functional Endoscopic Sinus Surgery
Hide Arm/Group Description:
Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment
Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
Overall Number of Participants Analyzed 73 60
Mean (Standard Deviation)
Unit of Measure: days
1.7  (1.3) 5.0  (5.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balloon Sinus Dilation, Functional Endoscopic Sinus Surgery
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Duration of study (minimum of 1-year) for all treated participants.
Adverse Event Reporting Description Participants continued to be followed every 6 months after completion of the 1-year follow-up until all participants had completed the 1-year follow-up. Adverse events were collected at all follow-up visits. Adverse events occurring after randomization for participants who did not undergo treatment are included until the time of their withdrawal.
 
Arm/Group Title Balloon Sinus Dilation Functional Endoscopic Sinus Surgery
Hide Arm/Group Description Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
All-Cause Mortality
Balloon Sinus Dilation Functional Endoscopic Sinus Surgery
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Balloon Sinus Dilation Functional Endoscopic Sinus Surgery
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/76 (1.32%)      2/75 (2.67%)    
Cardiac disorders     
Atypical Chest Pain  [1]  0/76 (0.00%)  0 1/75 (1.33%)  1
Gastrointestinal disorders     
Acute Gastroenteritis  [2]  1/76 (1.32%)  1 0/75 (0.00%)  0
Infections and infestations     
Infection  [3]  0/76 (0.00%)  0 1/75 (1.33%)  1
Indicates events were collected by systematic assessment
[1]
Participant underwent tests to rule out coronary artery disease. Participant withdrew before study procedure (unrelated).
[2]
Gastoenteritis reported at 118 days post procedure (unrelated).
[3]
Methicillin-resistant Staph aureus infection and cellulitis on the nasal tip reported at 276 days post procedure (unrelated).
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Balloon Sinus Dilation Functional Endoscopic Sinus Surgery
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/76 (0.00%)      0/75 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ellen O'Malley
Organization: Entellus Medical
Phone: 763-463-1598
EMail: eomalley@entellusmedical.com
Layout table for additonal information
Responsible Party: Entellus Medical, Inc.
ClinicalTrials.gov Identifier: NCT01525849    
Other Study ID Numbers: 1984-001
First Submitted: February 1, 2012
First Posted: February 3, 2012
Results First Submitted: November 1, 2016
Results First Posted: February 24, 2017
Last Update Posted: February 24, 2017