An interventional study of Balloon Sinus Dilation and Functional Endoscopic Sinus Surgery in Chronic Sinusitis, sponsored by Entellus Medical, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-24.
Sponsored by Entellus Medical, Inc. · Not applicable, Interventional, and Treatment
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.
415 studies on the registry are indexed under Sinusitis; 46 are open to participants now.
This study's enrollment of 151 is above the median of 60 across 313 interventional studies indexed under Sinusitis.
Browse Sinusitis studies →Entellus Medical, Inc. is the lead sponsor of 11 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
XprESS Multi-Sinus Dilation Balloon, FinESS Sinus Treatment
Device: Balloon Sinus Dilation
Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
Procedure: Functional Endoscopic Sinus Surgery
Balloon sinus dilation using the XprESS Multi-Sinus Dilation Tool or the FinESS SInus Treatment
Endoscopic sinus surgery, specifically, maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy
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).
Time frame: Baseline and 1-year
Debridements
Number of postoperative debridements per participant
Time frame: 1-year
Revision Rate
Number of participants requiring repeat sinus procedures
Time frame: 1-year
Complication Rate
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)
Recovery Time
Mean time (days) after procedure for participants to return to normal activities
Time frame: 6-months
Participants were screened, randomized, treated, and followed at 14 US centers from June 2011 to May 2014.
| Milestone | Balloon Sinus Dilation | Functional Endoscopic Sinus Surgery |
|---|---|---|
| Started | 76 | 75 |
| Treated | 74 | 61 |
| 6-months | 73 | 60 |
| Completed | 71 | 59 |
| Not completed | 5 | 16 |
| Withdrew: Lost to follow-up | 3 | 2 |
| Withdrew: Withdrawal by subject | 1 | 9 |
| Withdrew: Unrelated medical issue (not treated) | 1 | 2 |
| Withdrew: Anatomic exclusion criteria identified | 0 | 3 |
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).
| units on a scale | Balloon Sinus Dilation | Functional Endoscopic Sinus Surgery |
|---|---|---|
| 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 |
Number of postoperative debridements per participant
| debridements per participant | Balloon Sinus Dilation | Functional Endoscopic Sinus Surgery |
|---|---|---|
| Debridements | 0.23 ± 0.65 | 1.03 ± 0.87 |
Number of participants requiring repeat sinus procedures
| Participants | Balloon Sinus Dilation | Functional Endoscopic Sinus Surgery |
|---|---|---|
| Revision Rate | 1 | 1 |
Number of participants experiencing 1 or more serious adverse events related to the device and/or procedure
| Participants | Balloon Sinus Dilation | Functional Endoscopic Sinus Surgery |
|---|---|---|
| Complication Rate | 0 | 0 |
Mean time (days) after procedure for participants to return to normal activities
| days | Balloon Sinus Dilation | Functional Endoscopic Sinus Surgery |
|---|---|---|
| Recovery Time | 1.7 ± 1.3 | 5.0 ± 5.9 |
Collected over Duration of study (minimum of 1-year) for all treated participants.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Balloon Sinus Dilation | — | 1/76 (1.3%) | 0/76 (0%) |
| Functional Endoscopic Sinus Surgery | — | 2/75 (2.7%) | 0/75 (0%) |
| Event | Balloon Sinus Dilation | Functional Endoscopic Sinus Surgery |
|---|---|---|
| Atypical Chest PainCardiac disorders | 0/76 | 1/75 |
| InfectionInfections and infestations | 0/76 | 1/75 |
| Acute GastroenteritisGastrointestinal disorders | 1/76 | 0/75 |
All treated participants
| Age, Continuous(years) | Balloon Sinus Dilation | Functional Endoscopic Sinus Surgery | Total |
|---|---|---|---|
| Mean | 46.1 ± 13.6 | 47.8 ± 14.1 | 46.9 ± 13.8 |
| Gender(Participants) | Balloon Sinus Dilation | Functional Endoscopic Sinus Surgery | Total |
|---|---|---|---|
| Female | 48 | 36 | 84 |
| Male | 26 | 25 | 51 |
| Ethnicity (NIH/OMB)(Participants) | Balloon Sinus Dilation | Functional Endoscopic Sinus Surgery | Total |
|---|---|---|---|
| Hispanic or Latino | 6 | 5 | 11 |
| Not Hispanic or Latino | 68 | 56 | 124 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Balloon Sinus Dilation | Functional Endoscopic Sinus Surgery | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 4 | 1 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 4 | 6 |
| White | 65 | 56 | 121 |
| More than one race | 3 | 0 | 3 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Balloon Sinus Dilation | Functional Endoscopic Sinus Surgery | Total |
|---|---|---|---|
| United States | 74 | 61 | 135 |
| Sino-Nasal Outcome Test (SNOT-20) overall score(units on a scale) | Balloon Sinus Dilation | Functional Endoscopic Sinus Surgery | Total |
|---|---|---|---|
| Mean | 2.49 ± 0.88 | 2.52 ± 0.83 | 2.50 ± 0.85 |
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Entellus Medical, Inc.