A Phase 2 interventional study of RS-Series Rhinosinusitis Treatment System and FinESS Balloon in Sinusitis, sponsored by Entellus Medical, Inc.. Completed at 13 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-07-29.
Sponsored by Entellus Medical, Inc. · Phase 2, Interventional, and Treatment
This study is designed to evaluate safety and effectiveness of a less invasive procedure to treat maxillary only, or maxillary and anterior ethmoid, chronic sinusitis. Additionally, this study will assess the feasibility of performing the procedure under local anesthesia.
415 studies on the registry are indexed under Sinusitis; 46 are open to participants now.
This study's enrollment of 71 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.
A CT scan taken after maximal medical therapy (e.g., local or systemic antibiotics, topical steroids, etc.) must show one of the following:
Exclusion Criteria:
Balloon dilation with FinESS device
Device: RS-Series Rhinosinusitis Treatment System · Device: FinESS Balloon
Single arm
Incidences of Device-related or Procedure-related Complications
Time frame: Through 12 months post-procedure
Patency of the Treated Area as Verified by CT Scan
Post-procedure Patency was assessed using a CT scan 3 months post-procedure. The osteomeatal complex was assessed for patency by physicians.
Time frame: Post-treatment at 3 months
Symptomatic Score Change- Sinonasal Outcome (SNOT) 20 Score Improvement
Symptomatic change in SNOT 20 scores on a 5-point Likert scale where "0" = no problem to "5" = problem as bad as it can be were calculated. Baseline scores and 12 month post-procedure follow-up scores were calculated and compared. A score reduction of at least 0.8 (-0.8) from baseline to 12 months is considered statistically significant and clinically impactful.
Time frame: Post-treatment through 12 months
Enrolled patients with chronic rhinosinusitis (CRS) from Ear, Nose Throat (ENT) physician practices.
| Milestone | FinESS Sisnus System Balloon Dilation |
|---|---|
| Started | 71 |
| Completed | 67 |
| Not completed | 4 |
| participants | Treatment Group (ALL) |
|---|---|
| Incidences of Device-related or Procedure-related Complications | 1 ± 0.98 |
Post-procedure Patency was assessed using a CT scan 3 months post-procedure. The osteomeatal complex was assessed for patency by physicians.
| Ostia | FinESS Balloon Dilation |
|---|---|
| Patency of the Treated Area as Verified by CT Scan | 106 |
Symptomatic change in SNOT 20 scores on a 5-point Likert scale where "0" = no problem to "5" = problem as bad as it can be were calculated. Baseline scores and 12 month post-procedure follow-up scores were calculated and compared. A score reduction of at least 0.8 (-0.8) from baseline to 12 months is considered statistically significant and clinically impactful.
| Scores on a scale | FinESS Balloon Arm |
|---|---|
| Symptomatic Score Change- Sinonasal Outcome (SNOT) 20 Score Improvement | -1.8 |
Collected over 12 months post-procedure. Non-serious events are listed at a 1.4% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Group (ALL) | — | 1/71 (1.4%) | 0/71 (0%) |
| Event | Treatment Group (ALL) |
|---|---|
| Subcutaneous emphysema of the neck and upper chestSkin and subcutaneous tissue disorders | 1/71 |
| Age Continuous(years) | Balloon Dilation |
|---|---|
| Mean | 47.3 ± 13.7 |
| Sex: Female, Male(Participants) | Balloon Dilation |
|---|---|
| Female | 45 |
| Male | 26 |
| Region of Enrollment(participants) | Balloon Dilation |
|---|---|
| United States | 71 |
This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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Entellus Medical, Inc.