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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Balloon Sinus Dilation | Active Comparator | XprESS Multi-Sinus Dilation Balloon, FinESS Sinus Treatment |
|
| Functional Endoscopic Sinus Surgery | Active Comparator | Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balloon Sinus Dilation | Device | Balloon sinus dilation using the XprESS Multi-Sinus Dilation Tool or the FinESS SInus Treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline and 1-year |
| Debridements | Number of postoperative debridements per participant | 1-year |
| Measure | Description | Time Frame |
|---|---|---|
| Revision Rate | Number of participants requiring repeat sinus procedures | 1-year |
| Complication Rate | Number of participants experiencing 1 or more serious adverse events related to the device and/or procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Entellus Medical | Plymouth | Minnesota | 55447 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23920419 | Result | 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. | |
| 24823902 | Result |
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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.
Participants were screened, randomized, treated, and followed at 14 US centers from June 2011 to May 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Balloon Sinus Dilation | Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment |
| FG001 | Functional Endoscopic Sinus Surgery | Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All treated participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Balloon Sinus Dilation | Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment |
| BG001 | Functional Endoscopic Sinus Surgery | Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | All treated participants with matched pair SNOT-20 data at baseline and 1-year. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1-year |
|
Duration of study (minimum of 1-year) for all treated participants.
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Balloon Sinus Dilation | Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Gastroenteritis | Gastrointestinal disorders | Systematic Assessment | Gastoenteritis reported at 118 days post procedure (unrelated). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ellen O'Malley | Entellus Medical | 763-463-1598 | eomalley@entellusmedical.com |
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| Functional Endoscopic Sinus Surgery | Procedure | Endoscopic sinus surgery, specifically, maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy |
|
| Duration of study (minimum of 12 months) |
| Recovery Time | Mean time (days) after procedure for participants to return to normal activities | 6-months |
| 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. |
| 26228589 | Result | 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. |
| Unrelated medical issue (not treated) |
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| Anatomic exclusion criteria identified |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Gender | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Sino-Nasal Outcome Test (SNOT-20) overall score | 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). | Mean | Standard Deviation | units on a scale |
|
Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools. |
|
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| Primary | Debridements | Number of postoperative debridements per participant | All treated participants | Posted | Mean | Standard Deviation | debridements per participant | 1-year |
|
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| Secondary | Revision Rate | Number of participants requiring repeat sinus procedures | All treated participants with 1-year follow-up (or a revision surgery before 1-year follow-up if no 1-year follow-up). | Posted | Count of Participants | Participants | 1-year |
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| Secondary | Complication Rate | Number of participants experiencing 1 or more serious adverse events related to the device and/or procedure | All randomized participants | Posted | Count of Participants | Participants | Duration of study (minimum of 12 months) |
|
|
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| Secondary | Recovery Time | Mean time (days) after procedure for participants to return to normal activities | All treated participants with 6-month follow-up. | Posted | Mean | Standard Deviation | days | 6-months |
|
|
|
|
| 1 |
| 76 |
| 0 |
| 76 |
| EG001 | Functional Endoscopic Sinus Surgery | Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools. | 2 | 75 | 0 | 75 |
|
| Atypical Chest Pain | Cardiac disorders | Systematic Assessment | Participant underwent tests to rule out coronary artery disease. Participant withdrew before study procedure (unrelated). |
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| Infection | Infections and infestations | Systematic Assessment | Methicillin-resistant Staph aureus infection and cellulitis on the nasal tip reported at 276 days post procedure (unrelated). |
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